Links to 1084 Entry-Level Biotechnology & Life Science Jobs

The Research Associate, Bioanalytical will provide bioanalytical quantitative analysis of test compounds in biological matrices obtained from a variety of studies including preclinical safety evaluations and pharmacokinetic evaluations. Focus on small molecule analysis using LC-MS/MS. The candidate will be responsible for sample preparation from biological matrices, tissue homogenization, sample extraction techniques, and data acquisition.

The Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basisThe Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basisThe Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basis

The Product Surveillance Specialist effectively implements the complaint handling process and processes complaints in a uniform and timely manner according to regulatory requirements and company practices and policies. Evaluates complaints to determine whether an investigation is necessary and if Medical Device Reporting (MDR) is necessary in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals, Canadian regulations, European Vigilance Reporting and any other worldwide regulatory requirements.

Provide lead with work progress reports on a daily, weekly, monthly basis or as required Investigate and analyze patient charts and wound progress reports, by reading documents and negotiating computer-based research To develop, for each Medicare Insurance claim denial, a reasonable patient product use detail and history; to develop and substantiate the product use evidence, and present the patient’s case to Medicare in the manner required or make appropriate adjustments Write a medically concise and issue focused Redetermination, Reconsideration, or Administrative Law Judge letter as required as it applies to Medicare policy

The Associate Territory Representative (ATR) is the main point of contact on transition related sales activities. The role will focus on proactively generating sales revenue from transitions and coordinating with the Advantage Center on necessary paperwork relating to transition sales. The ATR will round floors on a daily basis to make sales and generate leads under the direction of the District Manager. The ATR will assist with account management activities including the setup of READYCARE and KCI Express and assist customers with invoicing, credit and collection issues, as well as conduct inventory management to recover lost assets.

The relevant experience required for a Clinical Education Specialist (CES) is a four year business degree or significant experience working with marketing activities, specifically digital marketing. The CES must possess a working knowledge of business principles, schedule management, organizational styles and marketing practices. The CES has the responsibility of supporting the Clinical Education Leader, President, and Director, R&D to move the company Up and Onward. The CES must assist to position Actuated Medical (AMI) as a company that Improves Patient Outcomes by developing Innovative Motion® Medical devices and providing clinical education to improve patient care.

This position is responsible for the inspection and packaging of product. Will perform all aspects of Inspection and Packaging with the ability to assist in day to day operations. Execute and document procedural steps in compliance with cGMP standards. Perform 100% visual inspection of product and classify rejected materials utilizing approved categories within required timelines (Qualification). Package product in final packaging components while verifying that lot information, including lot number and expiration date, are accurate

Execute tasks per cGMP guidelines and Standard Operating Procedures to manufacture, inspect and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing qualification block training program. Actively incorporate the Core Values set out by Emergent BioSolutions while performing day to day activities.

The Quality Control Analyst I, Microbiologist position supports the Quality Control group at EMOB to maintain process optimization and manufacturing activities. The Microbiologist is responsible for performing activities in support of the EMOB Microbiology, Environmental Monitoring, and Clean Utility testing programs, microbiological product testing, and supporting quality initiatives. Ensures samples are collected, tested, and reported per associated procedures and methods.  Responsible for quality document generation and revision, and quality notification execution.

The Facilities and Equipment Coordinator will serve the Facilities Department at the Adaptive Biotechnologies Seattle location. The primary function of this role is to support laboratory and building services including equipment maintenance and calibrations, equipment records, qualifications (IQ/OQ/PQ), and vendor coordination’s for the regulated and non-regulated lab space. This individual will provide cross-functional support for critical revenue driving assets and departments including the Production, Clinical Development, and Research Labs.  

The essential job function are to produce specified products by the mixing, blending, and combining of raw materials as specified by written procedures. This position is night shift working 12 hours shifts on a 2-2-3 schedule, for example working Monday and Tuesday off Wednesday and Thursday and working Friday, Saturday and Sunday then off Monday and Tuesday.

The Research Associate will work in a small team setting to support Adimab’s novel antibody discovery, maturation, and production platform. This role will closely interface with the Antibody Discovery, High Throughput Expression, Molecular Core, and Computational Biology teams. Assist in in-process antibody characterization, including ForteBio kinetics and binning. Run biochemical/biophysical assays, including but not limited to, Tm and endotoxin.

The Raw Material Specialist I will Perform quality control raw material processing and testing. Following general instructions on routine work and detailed instructions on new assignments. Perform quality control raw material processing, sampling and testing independently according to approved Standard Operating Procedures. Complete testing documentation and data entry as required for procedures and tests performed in-house and at contract labs.

It is mainly responsible for the manufacturing of plasma products through protein precipitation/separation and other tasks involving plasma receipt, plasma pooling, and protein separation. The Protein Purification Manufacturing Technician will also clean and sanitize equipment before and after use, make and verify connections on flow panels, perform pH and conductivity measurements, performs chemical and buffer additions and may assist Group Leader in training other tech positions.

Responsible for performing visual, mechanical and electrical inspections at subassembly and final assembly levels. Perform visual and mechanical inspections at sub-assembly and final assembly levels, using engineering drawings/specifications and general quality control standards. Review manufacturing documentation to ensure that all assembly, testing and inspection steps were performed in accordance to specifications.

As a part of our San Jose team, the successful applicant will work with other members of Consumables Production, as well as a multidisciplinary team of engineers and scientists, to support the assembly of microfluidic cartridges for biotech products. Key responsibilities include: Assemble reagents and consumables kits, Perform in-process QC and record results, Document production batch records/travelers, and computer data entry, etc.

As a Production Assistant 1, you will be responsible for the processing of raw biological material for use in product manufacturing. You will also perform maintenance and cleaning of production equipment and containers to ensure safety and compliance, as well as completing required paperwork.

As a part of our San Jose team, the successful applicant will work with other members of Consumables Production, as well as a multidisciplinary team of engineers and scientists, to support the assembly of microfluidic cartridges for biotech products. Operate and maintain robotic and manufacturing equipment, Document production batch records/travelers, and computer data entry, Perform in-process QC and record results

Responsible for performing QC testing for Value Assignment assays, QC release assays, stability, physical/visual inspections, any related QC function. Assists in the flow of product in the QC department. Coordinate, perform and maintain QC testing and scheduling for Stability program, Assist in establishing QC specifications, Assist in the validation testing of equipment and processes, etc.

Prepares compounded sterile products and performs related activities under the direction of a pharmacist. Responsibilities include: Prepares compounded sterile products using aseptic technique. Assists in the set up of the compounding room, equipment, and supplies for preparation of compounded sterile solutions, using aseptic technique. Performs general cleaning and maintenance duties as directed.

The Manufacturing Associate performs GMP manufacturing operations safely, reliably and in compliance with stated processes. Execute unit operations described in standard operating procedures and batch records. Perform bioprocess operations such as filtration, purification, cell culture or recovery. Clean, assemble/disassemble, sterilize and operate primary process equipment. etc.

This is a Development Associate I position in the Upstream Process Development group.  Primary responsibility will be to support mammalian cell culture processes used for the manufacture of therapeutic recombinant proteins.  The successful candidate will be responsible for supporting shake flask and bioreactor experiments, sampling, inoculating, feeding & harvesting bioreactors. Under general supervision, this person carries out routine to moderately complex experiments or procedures

This is a Development Technician position in the Process Development Support group.  Primary responsibility will be to support the process development team processes used for the manufacture of therapeutic recombinant proteins.  The successful candidate will be responsible for lab support. Under general supervision, this person carries out routine to moderately complex lab operations.

As an Electrical Engineer in our R&D group, you'll be part of a team that analyze, design, prototype and test new products for Agilent's Gas Chromatograph, Automated Sample Handling and Automated Sample Preparation products. Most projects require mechanical, electrical and firmware engineers, as well as chemists and software engineers, to create a complete system. As part of those projects, you will also work with our marketing, manufacturing, purchasing and service organizations to transform your designs into shipping products.

In this role you will play a big part in keeping our sample testing processes running smoothing by managing sample submission, receipt, and shipping coordination of all incoming test articles into Quality Control. You may focus in a specialized area and provide routine analysis and testing according to standard operating procedures for in-process and finished formulations.

he MQA Assistant ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems. This individual has the ability to work independently, within prescribed guidelines, and as a team member. This position promotes a cGMP environment and follows SOPs.

In this role you will be responsible for performing a wide variety of product inspection and packaging tasks. You will complete training and pass qualification testing for visual inspection of various product forms, perform accurate visual inspection and handling of products following SOPs while working under cGMP regulations.

The full-time, Development Engineer will have an opportunity to rotate through 3 areas of engineering within our Decatur, IL facility during their first year of employment – Maintenance, Projects and Technical.  

Revise and maintain controlled documents including, but not limited to: Master Batch Records, Standard Operating Procedures, Active Pharmaceutical Ingredient Specifications, Finished Drug Product Specifications, Forms, and Protocols.  Maintain and distribute Document Change Requests. Provide coverage for Front Desk.

Akoyais seeking an experienced Scientist to join our Quantitative Pathology Solutions –Phenoptics Services (QPS-PS), Image Analysis teamlocatedin Hopkinton, MA. Akoyaenables staining with up to eightantibodies utilizing our OPAL™ technology to provide unparalleled cellular/tissue imaging capabilities. QPS-PS is a dynamic team that develops multiplex OPAL™ panels for clients, then performs staining, imaging, and quantitative analysis of their samples. The QPS-PS Image Analysisteam focuses on imaging of stained slides and image analysis.

TYPICAL RESPONSIBILITIES: Processing next-generation sequencing data, such as RNA sequencing. Developing and applying algorithms such as clustering, principal component analysis and others to biological data such as gene expression information and immune repertoire data. Working with Amazon Web Services to process data. Querying and organizing an SQL database. Working with a team of consultants, data scientists, and computational biologists.

Responsibilities: Follow proper safety precautions and laboratory technique in the use of chemical compounds and reagents. Perform established analytical methods such as PCR (qPCR/ddPCR), Electrophoresis, and ELISA. Design, execute and report qualification assays under the supervision of senior group members. Write and revise documents such as SOPs and technical reports. Analyze data, identify trends and troubleshoot assays. etc.

We are seeking an experienced, high caliber Operator I. This position is responsible for the production of high quality medical devices within a manufacturing cell.

We are seeking an experienced, high caliber Operator I. This position is responsible for the production of high quality medical devices within a manufacturing cell.

AbbVie is looking for an Associate Scientist/Scientist, Chemistry with strong synthetic skills. This individual will work under the mentorship of a supervisor discovering, developing and executing routes to compounds to treat a variety of diseases. The candidate will be a member of an integrated Process Research & Development project team consisting of synthetic, structural, and analytical chemists and engineers whose goal is to identify and develop novel practical routes to newly discovered therapeutic targets. The ideal candidate will be enthusiastic and productive, with excellent communication skills and strong functional expertise in synthetic organic chemistry and compound synthesis and characterization.

We are seeking a dynamic Service Lab Senior Research Associate to work in our Cambridge, MA office to provide customers with quality data and analyses related to our high-throughput, multiplexed immunoassays and miRNA assays. The successful candidate will participate in every aspect of the Service Lab, from experimental design through running the assays, data analysis, report generation and supporting the customers as they interpret the results. etc.

We are currently hiring for a Software Engineer who has experience in digital signal processing and algorithm development. The candidate is responsible for designing, simulating, and implementing performance enhancing signal processing algorithms used in ABIOMED’s family of products. We are looking for a motivated and energetic self-starter, has a ‘make it happen’ attitude, and can thrive in a fast-paced, cutting edge environment. etc.

The Research Associate I will play a significant role in purification of protein biologics, and report to the Purification Group Leader. Core responsibilities include maintaining and operating chromatography instrumentation, conducting hands-on research for development of new techniques, and supporting ongoing protein purification activities. The ideal candidate will have a passion for scientific innovation, excellent technical skills, execute their responsibilities with high attention to detail, and work well within a team dynamic in a high-performance culture. etc.

Absorption Systems, provides analytical support for gene and cell therapy products through every stage of development, is seeking a candidate for either an Associate Scientist or Scientist position with GMP experience in molecular biology and gene expression at the headquarter location in Exton, Pennsylvania. Absorption Systems also provides non-clinical testing services to pharmaceutical and biotech companies to support research and development of drugs, biologics, and medical devices. etc.

Absorption Systems provides analytical support for gene and cell therapy products through every stage of development. Absorption Systems also provides non-clinical testing services to pharmaceutical and biotech companies to support research and development of drugs, biologics, and medical devices. Absorption Systems is seeking a candidate for either an Associate Scientist or Scientist position with drug transport and metabolism experience at the headquarter location in Exton, Pennsylvania. etc.

The Quality Control Technician will join Accelerate Diagnostics’ Consumable Operations team. This individual will be responsible for testing of incoming product both analytically and biologically in support of manufacturing. This will include, but not limited to, operation of pH/conductivity meter, spectrophotometer, refractometer and in-house biotechnology systems. This person will be part of a team that executes these tasks on a daily basis. The ideal candidate will be a team player, demonstrate excellent communication skills, be flexible, and excel in a fast-paced environment. etc.

Wright Medical is currently hiring a Sales Support Associate. The Sales Support Associate will be responsible for assisting in the successful execution of the sales plan for their assigned territory and the achievement of quarterly and annual sales plan objectives. He/she will travel within the territory and region for development & sales support. He/she will maintain open communications with their assigned leadership team and headquarter based sales training leader. He/she will perform and excel in case coverage, sales territory support functions and sales activity. He/she will achieve success with specified individual training and development plan. etc.

This position is responsible for assisting Sales Representatives in the district with the successful execution of sales plans for their assigned areas and the achievement of quarterly and annual sales plan objectives. This role includes essential functions such as the management of field sales operations, customer acquisition, cultivation & retention, product launch execution, inventory management, surgical case coverage, and travel within the district as well as maintaining open communications with their district leader. This is a field based position.

The Inventory & Sales Support Handler ensures the timely processing of kits/sets in the remote location. This could include, but is not limited to, checking in sets, verifying completeness, restocking, creating new kits from sterile implant SKUs, and other basic set maintenance. The Inventory & Sales Support Handler is required to function with minimal supervision to ensure that work flow is uninterrupted and that all customer requirements are met within the functional area. The Inventory & Sales Support Handler will ensure that all relationship and delivery functions are carried out timely and as needed. Driving abstracts will be required every year to ensure certification for driving company van. etc.

Performs Cell Culture and Cell-Based assays (BSL2 and BSL2+) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes batch records and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision. etc.

This position is responsible for operating process equipment and following all site operating, Quality, cGMP, and safety procedures associated with manufacturing of bulk medicated feed additives (MFA) from raw material to finished product. Incumbent must be able to clearly and frequently communicate with various functions within the site, including production, maintenance, quality operations, fermentation development, and administration. etc.

Assemble and test Point of Care medical Instruments. Process instruments according to all applicable procedures and quality requirements. Major Duties and Responsibilities – including but not limited to: Follow detailed operating procedures to assemble and test point of care medical instruments. Maintain productivity and quality requirements. Operate safely within a biohazardous environment.

Zymergen is hiring a distinctive Research Associate to develop technologies for high throughput DNA assembly and engineering of microbial genomes. The Research Associate will help create new technologies, bring in cutting edge protocols, and improve existing Zymergen protocols to provide newer and better workflows to our microbe engineering Factory. At Zymergen, the Research Associate will work together with other scientists, automation engineers, and software engineers to develop protocols for DNA cloning and microbial strain engineering, and then enable their use in high throughput workflows. etc.

This position requires the ability to execute daily tasks/requests with promptness and prioritize work in a fast pace environment. An ideal candidate for this position is organized, diligent, and displays excellent customer service skills. Job Description and Specific Responsibilities: Organizing and maintaining an inventory of laboratory supplies throughout the labs. Ensures material is available according to the production schedule. Performing daily cycle counts of designated inventory areas. Receive and verify material on a daily basis. etc.

We are seeking highly-motivated and proactive individuals to join our R&D team as a Research Associate. Working side by side with some of the most talented people in biotechnology, the successful applicant will participate in independent product research efforts targeted at driving either the development of novel, cutting-edge technology or improvements to products currently in our portfolio. The incumbent will have demonstrated clear leadership potential with ability to efficiently multi-task and manage a scientific research project, starting from the initial idea through to completion and publication in a peer-reviewed journal. etc.

Install or repairs a variety of building systems such as HVAC, compressed air systems and plumbing systems. Will install venting, plumbing and wiring required to support the production and/or development process. Performs skilled trades work, such as carpentry or painting in the construction, repair or alteration of structures such as walls, roofs or office fixtures; uses hand and power tools as directed. Makes periodic or special inspections of the premises to determine repair work necessary; performs routine repairs and maintenance to the facility. Works from blueprints, drawings or rough sketches. Produces rough sketches of projects and assists with the development of cost estimates. etc.

TA Instruments is seeking a Digital & UI/UX Designer to join in our growing Marketing team. Typical tasks of the position include, but are not limited to: Design, implement, test, and deploy innovative new features and functionality for corporate websites and other digital media to provide an outstanding user experience. Participate in cross functional teams to conceptualize and create new digital media that drives revenue. Research emerging technologies and trends in digital and web design that fit, support, and accelerate our goals. etc.

This position reports to the Concur Team Supervisor. The purpose of this role is to maintain the Global Concur Travel & Expense tool. The Concur system should reflect current Waters T&E policies and local regulatory requirements at all times and the Concur System Support is responsible for ensuring that it does. Responsibilities: Maintain the Concur system: groups, policies, roles and authorizations, negotiated rates for non-GDS suppliers. Configure Concur for changes to policies and rules. Manage data feeds to ensure: Employee data is up-to-date. etc.

WAVE Life Sciences USA seeks an experienced and highly motivated in vivo biologist. This position will primarily be based at Wave’s Worcester, MA site. This is an ideal position for an individual interested in drug discovery who would thrive in a team-oriented, fast-paced, and cross-disciplinary biotech environment. The candidate will be responsible for assisting in the design and execution of experiments as a member of teams focused on advancing therapeutic programs. This candidate will contribute to all levels of in vivo discovery research to support the development of nucleic acid therapies for genetic diseases. etc.

The Research Laboratory Technician assists with the biological sampling procedures required of each clinical trial and dictates tasks to Laboratory Assistants conducting the sampling activities related to each study. This position is responsible for assisting with the coordination of the preparation, collection, documentation, processing, inventory and shipment of biological specimens for clinical trials and reports to the Laboratory Supervisor. etc.

Westat is seeking a highly motivated web application programmer/developer who will be responsible for the development and implementation of web applications to support a variety of projects across our research domains. You will join a technical community of developers and engineers providing intuitive, responsive systems to collect high quality data using various leading edge technologies and modern software development tools and platforms. etc.

Westat has an immediate opening for a research assistant with experience in data collection procedures and materials along with a background in quantitative research and data analysis. The successful candidate will work closely with a multidisciplinary research team working on an innovative longitudinal health and aging study and a caregiving study. etc.

The Operations Associate has primary responsibility for carrying out all daily aspects of the operational work related to rater selection, rater certification/qualification, rater training content, scale acquisition, surveillance maintenance, workbook/source document, for Worldwide Clinical Trials, Inc. (WCT). The Operations Associate is responsible for ensuring all assigned projects are conducted in a timely fashion and in a manner compliant with SOPs and ICH/GCP/regulatory guidelines. The Operations Associate works under the direction of the Operations Manager, Clinical Assessment Technologies (CAT). etc.

Summary: This is an entry level sales position that will require you to learn our products, market and industry. This role will support our foot & ankle and biologics portfolio. Through determination, networking and market data, this position will seek out surgeons to educate, promote, market and sell these products in assigned geographic location. This is a field based position. etc.

Summary: This is an entry level sales position that will require you to learn our products, market and industry. This role will support our foot & ankle and biologics portfolio. Through determination, networking and market data, this position will seek out surgeons to educate, promote, market and sell these products in assigned geographic location. This is a field based position. etc.

Summary: This is an entry level sales position that will require you to learn our products, market and industry. This role will initially support our Hand, Wrist, Elbow and Biologics portfolio and may grow into selling the shoulder portfolio. Through determination, networking and market data, this position will seek out surgeons to educate, promote, market and sell these products in assigned geographic location. This position is a field based position. etc.

The Clinical Project Associate I provides administrative support to clinical research projects by assisting project teams in the completion of assigned project activities. This is an in-office position with that does not require travel. Essential Job Functions: Provides operational support for Clinical Operations. Under direct supervision prepares, reviews and distributes the regulatory documentation according to Essential Regulatory Document Guidelines and Trial Master File (TMF) Plan. Under direct supervision prepares the investigator regulatory binders and other study start-up materials, following established procedures. etc.

Performs basic protein based assays according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Under direct supervision, completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs additional Research & Development activities as assigned by Management. etc.

We are seeking a highly motivated and enthusiastic Technologist I / II to develop, optimize, and perform next-generation sequencing (NGS) assays in a CLIA/CAP laboratory. ESSENTIAL FUNCTIONS: Perform laboratory functions in accordance with standard operating procedures. Extract nucleic acids from various specimens including cell lines, human blood, fresh frozen tissue and Formalin-Fixed Paraffin Embedded tumor specimens). Participate in regular Proficiency Testing. Prepare auditing documents. Collaborate with the lab manager on all activities. etc.

Zeteo Tech, Inc, a venture backed company developing solution for Medical and Biodefense applications, is seeking a highly-skilled and motivated electrical or computer engineer with and interest in embedded systems. The ideal candidate should be interested in working in an entrepreneurial environment developing game changing solutions to healthcare and national security challenges. You will use your hands-on hardware and software engineering expertise to conceive, design, build, test and commercialize products. etc.

You will join a dynamic and agile team of scientists developing patient-derived 3D tissue culture models for cancer and immunology. You will be responsible for executing projects for our pharmaceutical clients ranging from screening of investigational compounds to exploring the mechanism of action of drug candidates. To be successful, you have to be excited by the fast-paced environment of a start-up and possess a versatile set of technical skills. etc.

Assist in the manufacturing of various chemicals, buffers, and other product-related components to ensure consistent product performance. Responsible for conducting quality control tests on various chemicals, buffers, and other product-related components. Essential Duties and Responsibilities: 1. Manufacturing: Assist the Technical Manufacturing Manager to manufacture chemicals, buffers, and cells for Zymo Research’s products. 2. Product Quality Control: Initiate and implement appropriate experiments according to the SOP in order to accept or reject the release of product(s) and other related product components. etc.

A team member responsible for technical contributions to the development, documentation, testing, analysis, troubleshooting, and debugging of the Company’s new medical devices, test and assembly fixtures, and data collection systems. Participates in the research and development of components and systems for the Company’s medical devices, utilizing knowledge of engineering theory and materials or component properties. Works within design controls and contributes to the design history file for medical devices by reviewing product requirements and specifications, documenting the design process, participating in formal design reviews and verifying the product performance with formal test methods, protocols and reports.

The Research Associate will perform analytical tests using HPLC, Spectrophotometry (RP, IEX, SEC, HILIC etc.), CE, mass with high quality and efficiency; provides analytical support in R&D settings for samples from various process scales; writes experiment summaries and development reports; and assists during document review comprising of but not limited to: batch records, standard operating procedures and assay protocols.

During your time this Program you may rotate into a variety of General Engineering positions throughout our organization, which may include, but is not limited to Manufacturing Engineering, Engineering – Stamping, Engineering Test Lab and Product Development Engineering. Designed for graduating seniors and early career professionals, this 2-year program accelerates participant’s development by combining intensive on-the-job training, rotations across business units, locations and roles, and exposure to senior leadership

Designed for graduating seniors and early career professionals, this 2-year program accelerates participant’s development by combining intensive on-the-job training, rotations across business units, locations and roles, and exposure to senior leadership. During your time in Electrical Engineering Program you may rotate into a variety of EE positions throughout our organization, which may include, but is not limited to Operations, Electrical/Plating Engineer, Electrical Testing Engineer, Electrical Component Engineer.

The Production Technician position performs all tasks involved in the pharmaceutical process following cGMP’s and SOP’s such as wet granulation, dry granulation, tablet compression, encapsulation, tablet coating, packaging and finished product, put product on stability. The position follows standard work methods and practices safe work habits to ensure production is as efficient and safe as possible.

Perform functions relating to the processing of Topical products (creams, ointments, lotions, solutions) ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements, and in conjunction with all Standard Operating Procedures (SOPs). Perform functions relating to the cleaning and sanitization of compounding process equipment and compounding facility to facilitate GMP compliance, quality, safety, and schedule attainment. Follow standard operating procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing.

Work within a cutting-edge genomics workflow to provide quality control support in a high-volume next-generation sequencing clinical laboratory. Document all results and findings in order to satisfy CLIA/CAP/NYS-DOH requirements. Report significant equipment findings/deviations and system deficiencies to lab management, as appropriate. Update SOPs and equipment records within document control system, including creation/ revision/ review of internal SOPs and other quality documentation.

The NPD Test & Evaluation Test Technician position is responsible for the preparation and testing of pre-production devices to support the product development process. The position is also responsible for testing support of competitor product evaluations for marketing information. Assisting in preparing the lab for simulated clinical evaluations and new product pilot lines is also included in the position. An additional responsibility is supporting the acquisition, calibration and validation of lab equipment.

Under general supervision, performs cGMP laboratory analyses of Finished products and in process materials. Performs stability testing for Finished products. Performs maintenance and calibration of analytical instruments. Operates general analytical instruments during the testing of finished products using HPLC, UPLC, GC-FID, UV-VIS, FTIR, automatic titrators, Dissolution Apparatus, particle size analyzer, Instron, Densitometer, Rheometer, viscometer (LV/RV/Cone and Plate), pH meter and analytical balance. Prepares standard, sample, and buffer solutions as required by test methods and performs all necessary calculations associated.

This position is responsible for performing operations related to the manufacturing and/or packaging of drug products through equipment set-up, operation, clean-up and maintenance in compliance with all regulatory requirements and company policies and procedures. Responsible for learning the manufacturing and/or packaging process as assigned by following approved batch records (BR), work instructions (WI), standard operating procedures (SOP), etc.

Multi-Craft Technician will maintain and trouble-shoot equipment within the manufacturing department. The technician will be fully trained in the operation of all manufacturing equipment before being trained specifically on the technical maintenance and repair Standard Operating Procedures (SOP’s). Responsible for electrical and mechanical troubleshooting of fluid delivery, extrusion, hydraulic, electrical, mechanical, and conveyance systems in a clean room manufacturing environment. The technician will be required to maintain Operating Technician proficiency and in case of emergency, may be required to assist starting and ending of batch processing

The Associate Data Scientist, Digital and Transformation will work with a multidisciplinary team to design and develop innovative data-driven analytical products and solutions for complex business problems using advanced analytics, data mining, and machine learning. Work with stakeholders throughout the organization to identify opportunities for leveraging novel statistical and machine learning techniques on data problems to solve strategic business questions. Should have a strong background and skill-sets related to programming and software development

The Scientist I, Manufacturing Sciences is responsible to manage and prioritize assigned projects related to development and improvement of DNA-based diagnostic reagents with supervision. Simultaneously manage and prioritize multiple projects and products across multiple functional groups while meeting target due dates with guidance of supervisor/lead. Design, create experimental task, run tests and be able to look at data and complete analysis using Fusion, Orchid, or equivalent software. Can provide experimental task(s) to designated Scientist with Supervisor approval.

Diagnose and repair, customer and in-process units. Keep accurate and ISO auditable records of product repairs, test results and other data as required. Adhere to ISO9000 requirements including ESD, work area cleanliness, maintenance and calibration of equipment and work instruction adherence

Perform job responsibilities in accordance with standard operating procedures (SOPs) and production records with an expectation of "Right the First Time". Assist in the set-up of semi-automatic filling equipment used to fill dermatological products. Perform routine sampling and inspections for product attributes (fill weights, product sealing, labeling) of filled products. Perform facility cleaning of manufacturing areas as required to maintain a cGMP environment and by Tolmar Standard Operating Procedures.

Under general supervision, develops the packaging components and packaging requirements for existing commercial products and for development projects.  Develops, maintains and monitors packaging components to ensure compliance with Quality, Safety, Manufacturing and Regulatory guidelines and procedures. Conducts testing activities that influence selection of primary, secondary and tertiary packaging components. 

The successful candidate will have interaction with Histology Research Associates, Histology Study Directors, Vet Care staff and interface with laboratory management regarding all day-to-day activities of the studies. They will be responsible for providing logistical support for the studies being conducted. As a laboratory assistant, you will be responsible for preparing animals for the studies conducted, including shaving, weighing and identification. Additionally, you will be responsible to ensure the technical conduct and regulatory compliance of your duties comply with FDA GLP and ISO regulatory guidelines. 

Product Development R&D Scientists perform preformulation and formulation development activities, prepares formulation batches for compatibility studies, stability studies, Pilot batches and Pivotal batches, perform maintenance of Research and Development (R&D) equipment/instruments.

The Vaccine Process Development and Commercialization group within our client's manufacturing division focuses on late stage process development, technology transfer, and support of established vaccine products.  Our client is seeking an energetic, people-oriented professional with strong scientific and technical skills to execute the tech transfer activities of multiple vaccine programs with a focus on upstream manufacturing process ( Drug Substance ).

The Associate Test Engineer – Medical Device will manage the investigation of device product complaints.  This individual will develop, document, and execute medical device test protocols; Enhance/automate test processes; Support the engineering team with testing, prototyping, and reworking activities; Responsible for equipment calibration and general lab organization.

We are currently looking for a Process Engineer to join our API team.  In this role, you will support the process engineering team in the specification, installation, maintenance and operation of small-molecule API production equipment and processes.  Additionally, you will partner with members of the API Production and R&D team on activities as required to help internal customers efficiently produce the best medicines possible.

Support the development, execution and analysis of assays in early clinical studies to assess ACTR T cell persistence and phenotype, target expression/occupancy, cytokine levels and immunogenicity. Explore predictive biomarkers of ACTR manufacturing and clinical success across various patient populations. Prepare data packages for technical reports, SOPs, and regulatory submissions

As an Associate Neuroscience Specialty Representative, you will be responsible for: Becoming knowledgeable of disease state, product and competitive market knowledge. Educating Healthcare providers on Vanda's product portfolio. Developing relationships with Healthcare providers in order to understand their needs.

As an Associate Neuroscience Specialty Representative, you will be responsible for: Becoming knowledgeable of disease state, product and competitive market knowledge. Educating Healthcare providers on Vanda's product portfolio. Developing relationships with Healthcare providers in order to understand their needs.

As a Hardware Verification Engineer, you will own verification activities on new and released products. Your responsibilities will include: Collaborate with cross functional teams to ensure that Varian’s complex devices are thoroughly tested. Collaborate on requirements definition and test acceptance criteria. Develop manual and automated test methods to characterize performance of new devices from prototype to production.

We currently have an opportunity for a Quality Assurance Engineer for our Palo Alto facility. In this key role, the Quality Assurance Engineer will manage implementation, support, and maintenance of company-wide quality objectives, including analysis and trending of key quality system elements on a periodic basis.

Using NetSuite and web-based research to understand customer organizations and working with colleagues at Vector Laboratories and at each account to understand buying trends and purchasing mechanisms. Meeting and exceeding sales targets by establishing strong business relationships with current and future customers and aggressively pursuing new sales opportunities. Engaging with purchasing decision-makers at each account, establishing relationships, evaluating, prioritizing, and uncovering sales opportunities and customer concerns.

Help us design our solutions. Contribute to technical and functional design decisions, troubleshoot and provide technical product support, and be responsible for all aspects of the software development lifecycle. Drive all aspects of the software development cycle: design, implementation, tuning, testing, and monitoring of the functional areas that you will own, delivering products within the schedules and timelines

Work with product managers and developers using Agile methods to identify/refine test cases from requirements and design. Work with developers and other QA engineers in a team environment to ensure product quality. Document test cases and outcomes within a test case management application. Conduct QA tests and verify outcomes within schedules/timelines. Clearly document and explain defects found in defect tracking system.

The candidate will get rotated through all the departments in the plant and once that has been completed you will be assign to the department that best fits the needs of the plant and is a fit for your background. Potential experiences include product design, customer order engineering, application engineering, quality engineering and manufacturing engineering.

Software Engineer needed to join the Teamcenter Visualization development team, with most team members located in Ames, Iowa. Design, develop, maintain and test software programming for Siemens PLM products with focus on achieving high quality and on time delivery of the software solution. Ensure the overall functional quality of the released product on all required platforms.

Responsible for aiding in the continued research and development of current and future activities and projects related to corneal transplantation and cell therapy following GCP and GMP guidelines. Design and execute laboratory processes according to established protocols. Maintain records of observations and interpret findings. Continually assess procedures and look for process improvements. Organize and store all chemical substances, fluids and compressed gases according to safety instructions.

Under the direction of the Technical Program Manager and Director at CorneaGen - Boston, the Laboratory Support Technician will assist in tissue processing and distribution related operations, and tissue suitability activities. The incumbent will be expected to steward each donor’s Gift by ensuring standardized operational practices are effectively executed at the local level and by seeking continual improvement opportunities to maximize the value of the Gift

Support the Quality Control function with respect to raw material, in-process, release and stability testing. Collaboratively participates in Development functionsfor the company including pre-formulation, formulation, process and analytical development activities. Operate various lab instruments and equipment including (but not limited to): Karl Fisher, pH, HPLC, FTIR, UV-VIS, DSC, TOC, Lab-ware washers, Autoclave, Laminar Flow Hoods, Bio-Hazard Hood, Microbalances, and other diverse lab equipment and various wet chemistry techniques.

Responsible for hands-on execution of all activities in the manufacturing area including the processing and packaging of human tissue products for transplantation. All duties are performed in compliance with FDA cGMP/cGTP requirements, American Association of Tissue Banks (AATB) standards, and Osiris Therapeutics Inc. standard operating procedures (SOPs).

The Quality Assurance Inspector 1 shall be responsible for performing basic visual/dimensional/functional inspections of incoming purchased product as well as product manufactured/assembled in-house, determining whether or not product meets specifications and documenting these decisions.   

The Quality Assurance Inspector 1 shall be responsible for performing basic visual/dimensional/functional inspections of incoming purchased product as well as product manufactured/assembled in-house, determining whether or not product meets specifications and documenting these decisions

The candidate will be responsible for writing and editing high quality study reports for several technology groups, including ecotoxicology, environmental fate and metabolism, avian and analytical chemistry, in addition to production of other documents as needed. Prepares study reports from data presented in technical format that meets guideline requirements. Compiles and incorporates comments from several different levels of review.

The Analytical Sciences team is seeking a Research Associate to assist in the identification and characterization of SOMAmer® reagents. This position works in a fast-paced, team-oriented research group. The individual will primarily perform sample preparation of protein pulldown samples for LC-MS analysis and also generate new SOMAmer reagents using the SELEX process. Detailed documentation, critical evaluation and communication of results are essential traits for this position. Level will be commensurate with experience.

We are currently seeking a Downstream Manufacturing Associate I. This position is tasked with supporting all aspects of downstream manufacturing processes. For GMP-qualified campaigns this involves large scale buffer preparation, column chromatography using the Akta Process system and large bed volume columns, various filtration methods, ultrafiltration/diafiltration methods, and formulation. This position will also be responsible for supporting the inventory control for the downstream group.

As an Associate Scientist you will work in the Antibody Analytics group and be responsible for the development, implementation and maintenance of a variety of analytical assays to support R&D in protein therapeutics including monoclonal antibodies, bispecific antibodies, antibody-drug conjugates (ADC) and CAR-T. These assays include but not limited to chromatography (SEC, IEX, HIC and RP), electrophoresis (SDS-PAGE and CE-SDS), and icIEF

Provide support to the Clinical Trial Managers and Clinical Research Associates in clinical trial conduct via preparation, distribution, and tracking of study supplies, mass mailings, copying, data entry, etc. Recognize the urgency of meeting established schedules and be able to prioritize tasks and time to meet those schedules. Develop materials that support the conduct of clinical studies including: site reference manuals, monitoring flow sheets, CRF completion guidelines, etc.)Demonstrate superior communication and organizational skills in addition to the technical skills required for overseeing clinical studies.

Research involves use of physiological data acquisition systems including measurement of EEG, EMG, body temperature and locomotor activity. Must be able to carefully follow established research protocols and to reliably make solutions following written recipes. Ability to research scientific literature to help interpret experimental results and to suggest modifications of experimental procedures is important. Good record keeping and data management are essential.

Based in Princeton, NJ, the candidate would join a multidisciplinary group dedicated to the development of custom image sensor devices, modules, and systems for numerous commercial, spacecraft, and government applications. Design mechanical parts, and assemblies using SolidWorks. Verify designs using SolidWorks Simulation and SolidWorks Simulation Professional.

The Packaging Process Technician will provide quality oversight to the packaging processes and functions during the inspection and cartoning of commercial product lots.  Direct support and oversight will be provided to internal departments to ensure compliance of cGMP standards and FDA regulations.  Additionally, the Packaging Process Technician will perform real time review and approval of PBRs and supporting documentation accompanying the packaging processes and work with appropriate Line leads/Supervisors to ensure documentation errors or issues are resolved.

The Systems Verification Engineer I & II will contribute in defining, documenting, performing, and analyzing verification tests for hearing aids, accessories, manufacturing software, fitting software, mobile applications, programmers, their components and sub-systems. The responsibilities of the Systems Verification Engineer I & II may include the automation of product system verification tests which require additional software engineering capabilities and experience. S/He must have the ability to work both independently and in a group environment.

Manage lead generation and tracking using the CRM Salesforce, the marketing automation system Pardot, social media platforms, web traffic tracking systems, and other marketing tools. Manage and build the current database for both business units. Create content using these marketing tools, including regular marketing emails, social media posts, website content, conference materials, print collateral, and other communications as needed for both business units

Provide on site and remote service and support of Stereotaxis magnetic navigation systems including permanent magnets, and servo control systems.  Interface with customers and vendors to ensure a quality service experience and that all expectations are met.

The primary role of the Repair Technician is to perform repairs on medical instrumentation.  Technicians will be trained to become familiar with various types of surgical instruments and understand how to best maintain and repair them.  Repairs are completed on a repair truck onsite at a hospital or surgery center.  In addition to repair work, Technicians may work with a team including Sales Representatives and RCs (Repair Consultants/Managers) to identify and capitalize on revenue opportunities. 

Responsible for receiving and shipping medical instruments, devices, component parts and miscellaneous items into and from the repair facility by performing the following duties.  This position may have responsibility for the disinfection control process of medical instruments/devices received.

 Candidates will be involved in synthesizing the unique building blocks for our novel DNA sequencing technology, developing and optimizing synthesis protocols, as well as proposing and executing innovative experiments to push our technology forward.  The position is salaried with hours dependent on lab needs and project deadlines.

Processes surgical sets to fulfill daily set orders and assists with other responsibilities held by Stryker Loaner Operations team. Develops an understanding of all Stryker product offerings through the repetition of processing loaner sets, beginning with small less complex sets then working up to larger sets containing both implants and instrumentations. Performs initial quality checks on instrumentation ranging from simple visual examinations to more complex functional checks

The QC Microbiologist performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. Record GMP data, monitors and evaluates QC systems and equipment. Interact with internal and external auditors including government agencies and contract manufacturing representatives.

Ensure the well-being of volunteers and that adverse events are gathered and documented. * Perform the full spectrum of technical activities related to the field of expertise. * Perform catheter insertion and venipuncture. * Measure vital signs within the required timeframes. * Performs intradermal, intracutaneous and intramuscular injections. * May be called upon to insert nasogastric tubes and to perform any other tasks for projects. * Prepare, collect and process pharmacokinetic and pharmacodynamic samples. * Measure physiological data (weight, height, bone structure). * Perform electrocardiograms. * Collect and process diagnostic samples (alcohol breath tests, urine samples). * Ensure that the informed consent form is read, details study specifics, and answers volunteer questions.

SBI seeks to hire a customer and technical support representative. The ideal candidate will have a B.S. degree in the life sciences and will support an existing group of customer support personnel taking telephone orders from customers, logging into a CRM system, printing packing slips, sales orders, and shipping documentation, and assist with packaging of life science reagents for shipment to worldwide customers. This position will also provide support to the Commercial Team.

The Production Associate (PA) is responsible for executing all processes in production at Takeda’s manufacturing facility in Round Lake, Illinois, while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply; fully participates in both departmental projects and any quality working teams which may be applicable; under the general direction of the lead technician and the overall direction of the supervisor, responsible for the hands-on execution of all activities in the production area

We are looking for a Sales Support associate to join our team. You will be a partner to the Sales team and manage the operational steps required to effectively engage, retain and support our existing customers ongoing needs related to their Veeva software subscriptions. Our ideal candidate is a motivated, goal oriented, recent college graduate who is interested in developing sales support and customer service best practices. We expect you to perform well in a team environment and have exceptional communication skills. Ultimately, you should be able to create and maintain good customer relationships and help support sales team operations. etc.

Do you want to be a part of a dynamic group that tests and validates novel compounds in preclinical model systems? In this position, you will support our entire in vivo team by performing efficacy, PK, and other experiments. In addition to rodent work, part of this position will require coordinating and managing samples at contract research organizations (CROs). In our newly-built South SF laboratory, you will help our in vivo team discover novel targets in neurodegenerative diseases. We are looking for detail-oriented and self-motivated individuals who are looking to make a difference in patients’ lives. etc.

Perform microbiological assays for in-process and final product samples. Perform analytical methods for final bulk material/finished goods. Test and disposition of raw materials and perform environmental monitoring. Review of QC data for compliance to procedures and specifications. Calculate and evaluate results. Participate in lab maintenance and administration duties. etc.

The Network Support Associate is responsible for user and desktop support (hardware and software), computer repair, helpdesk, and application support. S/he performs a variety of information technology support duties to ensure smooth delivery of technology services throughout the organization, providing consistently high service levels to internal customers. As a Network Support Associate You Will… Install, monitor, operate, coordinate, assist, and train others in the operation of computer hardware, software, and peripherals to meet customer needs. Utilize computer equipment, software, and diagnostic tools to perform a broad range of customer assistance, equipment maintenance, and repair assignments. Exercise judgment and creativity in selecting and applying procedures correctly, and determines when to escalate issues to the next level of support. etc.

Vertex Pharmaceuticals is looking for an Administrative Assistant to support the Corporate Communications and Corporate Social Responsibility (CSR) team in Boston, MA. This position is responsible for performing a variety of administrative duties across the Corporate Communications team. The Administrative Assistant must have proven experience in building collaborative relationships among his/her superiors, peers and subordinates. The ability to embrace and enhance Vertex’s culture is paramount to success in this role. The candidate must have strong achievement drive, with an impeccable work ethic, able to provide full support to enable the team to maximize their productivity and time. The Administrative Assistant plays an important role in ensuring the effective and efficient maintenance of departmental processes, procedures and programs inclusive of travel arrangements, calendar management, scheduling, Purchase Orders, vendor meetings and expenses. etc.

Perform lab experiments as planned and document all observations and findings. Prepare hybridization capture NGS libraries and amplicon panel NGS libraries. Analyze and interpret data. Present experimental findings and interpretations to senior research team members. Demonstrate potential for technical proficiency and ability to collaborate with others. Participate with other R&D team members in troubleshooting and identifying new opportunities for optimization, applications, or products.

As a member of the Cell Manufacturing/Combination Product team, incumbent will perform a broad range of tasks in the cGMP manufacture of cells and combination cell therapy/device products for use in clinical and developmental studies. This position includes hands-on participation including materials logistics, assisting in manufacturing operations, and may include non-routine development activities. This is a full time position. etc.

This position has the authority to stop production at his/her work station when there is question or concern about the acceptability of materials, subassemblies, assemblies and processes that affect the quality and safety of Viant products. ESSENTIAL JOB FUNCTIONS: Performs assembly per approved documentation and training. Performs equipment set-ups. Inspects product and paperwork for compliance to production standards. Identifies areas for process improvement and makes recommendations to supervision. Reviews documentation for completeness and accuracy. Maintains high standards in quality and throughput. Applies common sense understanding to carry out detailed written and oral instructions. Demonstrates understanding of the product and process flow for assigned work area. etc.

As the Manufacturing Operations Engineer, you will wear many hats in supporting a fast-growing robotic surgical company. This role will coordinate with multiple internal departments to set-up best practices in operations, manufacturing, inventory control, inspection, and material flow. As we expand into new space, you will be tasked with everything from production floor set-up to strategic development of layout and processes. To succeed in this role, you will need to be a good communicator with a strong sense of urgency, flexibility, and a self-starter attitude. This role reports directly to the Vice President of Operations. etc.

The Upstream Manufacturing Associate applies a broad knowledge of biological, bioprocess, and mechanical principles to execute complex operations that result in clinical and commercial stage medicines to dramatically improve the human condition through gene therapy. We believe this path may lead to real cures. You could be part of what many thought was not possible! Responsibilities: Perform downstream purification activities such as Chromatography, TFF, Ultracentrifugation, and Final Formulation steps. Perform various filter integrity tests throughout the process. Document all activities in Batch Records, Logbooks, Forms, etc.

As a part of the Upstream Process Development team, the Scientist/Engineer is responsible for working with clients to evaluate upstream processes and ensure proper technology transfer from clients. In addition, the Scientist/Engineer will develop robust seed train and bioreactor processes and scale-up upstream processes to ensure successful transfer to cGMP manufacturing. Responsibilities: Working with clients in evaluation of upstream processes, sourcing reagents, equipment, and materials for specific projects and ensuring proper technology transfer from client. Process demonstration using bench-top bioreactors. Development of optimized, characterized, and robust seed train and bioreactor processes. etc.

The Laboratory Data Entry QC Review associate is primarily responsible for the review and audit of order entry information and performing duties with a high degree of proficiency. Employee Responsibilities: Demonstrate data entry proficiency with the Laboratory Information Management System (LIMS) and/or other test ordering systems. Ability to prioritize and organize efficient work flow, demonstrating excellent time management skills. Ability to maintain detailed and accurate records with great attention to detail, according to good documentation practices. Make appropriate internal or external contact to resolve patient demographic issues or discrepancies. Complete correction requests as needed in a timely manner. etc.

This is a Full Time position. Schedule is Tuesday – Saturday, 8:30 A.M. – 5:00 P.M., with overtime as needed. Demonstrate data entry proficiency with the Laboratory Information Management System (LIMS) and/or other specimen tracking system. Examine samples for accuracy and other requirements (sample type, stability, volume, etc.). Label samples for delivery to proper area(s). Use and maintain applicable sample storage materials (i.e. dry ice). Make appropriate internal or external contact to resolve patient demographic issues or discrepancies. Complete correction requests as needed. Adhere to all Data Management policies and protocols. etc.

The Research Scientist is primarily responsible for conducting research, development, validation and execution of assays to meet the development requirements within corporate/client timelines and cost objectives. Learn new techniques and instrumentation. Implement research plans, designs and testing protocols. Operate, calibrate and maintain all laboratory equipment and instruments according to standard operating procedures to ensure quality results. Keep accurate documentation of all research project steps according to Viracor Eurofins regulatory guidelines. Complete scientific write-ups of results and methods of performed experiments. Accurately prepare, label and store reagents, standards, controls, proficiency testing material and patient specimens for analytical, clinical and biopharma validations analysis and short and long-term storage. etc.

We are seeking an experienced and highly motivated biologist to contribute to our biochemical and molecular biology research team at our facility in Cambridge, Massachusetts. This is an ideal position for an individual with a background in molecular and cellular methods, who thrives in a team-oriented, fast-paced, and cross-disciplinary small biotech environment. The individual will work at the bench on multiple projects and be responsible for experimental execution and data analysis for research studies supporting therapeutic programs and platform discovery research. We are looking for prior hands-on experience with techniques such as DNA/RNA isolation from tissue, RT-qPCR, ddPCR, Western blot, and ELISA.

Voyager Therapeutics seeks a highly motivated and experienced molecular biologist to contribute to its research team at its facility in Cambridge, Massachusetts. The candidate will be involved in novel AAV capsid discovery, screening AAV variant libraries in small and large animals and engineering capsids for desired properties. This is an ideal position for an individual with extensive hands-on cellular and molecular expertise, who has a can-do attitude and strong work ethic, and thrives in a team-oriented, fast-paced, and cross-disciplinary start-up biotech environment. This position reports into the Scientist II, Vector Engineering.

As a Design Assurance Engineer you will review test plans and protocols, Design History files, ISO13485 requirements and CFR820 design control requirements to ensure that medical device/equipment products meet all quality standards. Oversee product quality throughout the entire product design realization process. Work closely with research and development to support new product development and improve product design. Remediate legacy design files, risk files and DHF’s and develop a harmonized DHF system for new and legacy products for Vyaire. This position will primarily focus on DHF remediation in complying with the new European standards to comply with MDR.Work under general supervision with latitude for independent judgment. Required to consult with senior peers on certain projects as required. etc.

This position requires the flexibility to function in all three areas: Material Handling, Shipping Clerk and Receiving Clerk: Material Handler: Verify quantities, lot numbers, and part numbers against documentation previously prepared. Issue and move components, supplies and printed materials from the warehouse to meet manufacturing and intra-company requirements. Stage raw materials for Issuance Group dispensing. Assist in raw materials dispensing as required. Verify and receive materials returned from manufacturing in a timely manner. etc.

Assist in the set up and operation labeling equipment used to label pre-filled syringes and/or vials, including equipment in the sterile support areas. Properly load pre-filled syringes and/or vials into labeling equipment. Assist in the set up and operation of semi-automatic packaging equipment used to package pre-filled syringes. Properly load pre-filled syringes and components into semi-automatic packaging equipment. Accurately document production activities using regulatory controlled documents including production records and log books. etc.

Assist in the set up and operation labeling equipment used to label pre-filled syringes and/or vials, including equipment in the sterile support areas. Properly load pre-filled syringes and/or vials into labeling equipment. Assist in the set up and operation of semi-automatic packaging equipment used to package pre-filled syringes. Properly load pre-filled syringes and components into semi-automatic packaging equipment. Accurately document production activities using regulatory controlled documents including production records and log books. etc.

Toxikon is seeking an entry level lab assistant to work in the In Histology. The successful candidate will have interaction with Histology Research Associates, Histology Study Directors, Vet Care staff and interface with laboratory management regarding all day-to-day activities of the studies. They will be responsible for providing logistical support for the studies being conducted. As a laboratory assistant, you will be responsible for preparing animals for the studies conducted, including shaving, weighing and identification. Additionally, you will be responsible to ensure the technical conduct and regulatory compliance of your duties comply with FDA GLP and ISO regulatory guidelines. etc.

Toxikon is seeking an entry level lab assistant to work in the In Vivo Biocompatibility department. The successful candidate will haveinteraction with In Vivo Research Associates, In Vivo Study Directors, Vet Care staff and interface with laboratory management regarding all day-to-day activities of the studies. They will be responsible for providing logistical support for the studies being conducted. As a laboratory assistant, you will be responsible for preparing animals for the studies conducted, including shaving, weighing and identification. Additionally, you will be responsible to ensure the technical conduct and regulatory compliance of your duties comply with FDA GLP and ISO regulatory guidelines. etc.

We have a unique opportunity for an entry level to intermediate Scientist to perform laboratory analyses in the testing of raw materials for release, in process (IP), finished products (FP) during process validation and stability (ST) samples of test batches and to carry out laboratory work to support method validation activities. This position is located at our Monmouth Junction, NJ facility. Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws. Operates general analytical instruments during raw material, in process and finished product testing such as HPLC, GC, UV/Vis, automatic titration, IR, AA, TLC and dissolution apparatus.We have a unique opportunity for an entry level to intermediate Scientist to perform laboratory analyses in the testing of raw materials for release, in process (IP), finished products (FP) during process validation and stability (ST) samples of test batches and to carry out laboratory work to support method validation activities. This position is located at our Monmouth Junction, NJ facility. Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws. Operates general analytical instruments during raw material, in process and finished product testing such as HPLC, GC, UV/Vis, automatic titration, IR, AA, TLC and dissolution apparatus.

QC Chemists perform analytical testing of raw materials, packaging component, in-process, finished product, stability samples, cleaning verification/validation, and process validation samples following Analytical Methods, Protocols, Procedures (SOP’s) and company policies. He/she follows and maintains adherence to current industry standards (cGMP’s, GLP’s, etc.) to meet production and customer demand. Qualified candidates will be expected to work either independently or as a team to achieve company goals and initiatives. etc.

The Systems Support Specialist – Operational Technology will provide basic technical support for manufacturing and manufacturing support systems in a regulated, validated environment. Provide first level technical support of manufacturing and manufacturing support systems including but not limited to; answering questions, resetting passwords Troubleshoot and maintain OT computers, peripheral equipment and software Work with vendor support contacts to resolve technical hardware and / or software problems, escort vendors on the premises, answer basic questions, oversee work being performed Enter, update and follow up supp+H10:H14ort requests in OT’s issue tracking system Provide first level systems training to end users Other duties as assigned

We are seeking a highly motivated individual to join TP Therapeutics as a Clinical Trial Associate (CTA) within the Clinical Operations Team, reporting into the Director of Clinical Operations. The Clinical Trial Associate is responsible for the oversight and management of clinical operations activities or projects. The CTA will interact with Clinical Operations teams and collaborate effectively with CROs, vendors and clinical trial sites. The CTA supports the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. etc.

The Systems Support Specialist – Operational Technology will provide basic technical support for manufacturing and manufacturing support systems in a regulated, validated environment. Provide first level technical support of manufacturing and manufacturing support systems including but not limited to; answering questions, resetting passwords. Troubleshoot and maintain OT computers, peripheral equipment and software. Work with vendor support contacts to resolve technical hardware and / or software problems, escort vendors on the premises, answer basic questions, oversee work being performed. Enter, update and follow up support requests in OT’s issue tracking system. Provide first level systems training to end users. Other duties as assigned.

The primary role as an Associate Scientist will be to use and develop immunoassays and bioassays to enhance understanding of key attributes in support of cell therapy process and product development and characterization. Participate in activities to support Unum’s pipeline within established timelines and ensure data quality and integrity. Participate in design and execution of experiments and complete laboratory testing. Analyze and present experimental data at departmental and company meetings. Follow good documentation and review practices, and effectively communicate scientific results in presentations and written reports. Draft standard operating procedures and test protocols in support of analytical development.

The Packaging Tech II - 3rd shift (9:00 PM - 5:15 AM) is responsible for demonstrated expertise on one or multiple production lines and to ensure safe, quality pharmaceutical product packaging. This position sets up, adjusts and troubleshoots pharmaceutical packaging machinery and ensures that packaging operations are completed per standard operating procedure. Essential Duties: Executes packaging line operations, processes and procedures. Coordinates the packaging efforts for designated production lines and teams. Completes machine set up, operations, tooling changes, adjustments and troubleshooting related to the operation of one or more packaging lines. etc.

The Lab Tech performs routine analytical physical attribute testing. Assists laboratory analysts with solution preparation, simple sample preparation, and clean up as requested. Disposes of laboratory hazardous waste as necessary. Performs routine maintenance on select laboratory equipment and ensures laboratory safety-equipment is functioning properly. Familiar with basic laboratory techniques (e.g. pipetting, weighing, pH). Documents all laboratory work according to internal SOPs, test methods, and cGMPs. etc.

The Packaging Tech II - 1st shift (5:00 AM - 1:15 PM) is responsible for demonstrated expertise on one or multiple production lines and to ensure safe, quality pharmaceutical product packaging. This position sets up, adjusts and troubleshoots pharmaceutical packaging machinery and ensures that packaging operations are completed per standard operating procedure. etc.

Addresses and resolves basic incidents and requests; logs all incidents and requests; engages other service desk resources or appropriate service resources to resolve incidents that are beyond the scope of their ability or responsibility. Uses the appropriate categories for logging incidents and requests. Creates a positive customer support experience and builds strong relationships through deep problem understanding, ensuring timely resolution or escalation, communicating promptly on progress, and handling customers with a consummately professional attitude. Ensures the end-to-end customer experience and provides a single point-of-contact for the customer. Analyzes and resolves incidents and requests regarding use of application software or hardware. etc.

We are seeking a highly motivated engineer to join the Pharmaceutical Development group supporting process development for respiratory drug products. Support development and optimization of engineered particle inhaled dosage forms. Specific methods may include bench and pilot-scale spray drying. Perform physicochemical property and aerosol performance characterization of solid-based inhalation dosage forms

Analyze raw materials, in-process, and finished products assuring compliance with company  standards and applicable government regulations. Work closely with R&D analytical development to ensure a smooth transfer of methods. Perform qualitative and quantitative testing on routine and non-routine samples using technique analytical equipment to highly sophisticated and automated instrumentation.

Under general supervision, perform various manufacturing related activities for a GMP compliant Fill/Finish operation applying standard practices, techniques and procedures.  Able to assist in the preparation of reports, records, etc., for assigned tasks.

An Associate Scientist in our Bioanalytical department will be a fully-supervised trainee, responsible for sample preparation by various extraction methods; analysis of drug and metabolites in biological samples to support preclinical and clinical drug development programs under GLP regulations; and recording study results and observations. Perform routine lab operations, such as sample extraction, preparing reagents, operating automatic liquid handling equipment, pipetting, weighing, monitoring, and recording, in a neat/clean manner

This junior level associate is a key member of QPS’ DMPK lab support team, ensuring that client samples and other controlled materials are received, stored, distributed, tracked and returned safely, securely, confidentially and without loss or damage. This role requires comfort with computer systems and databases, and requires independence, attention to detail, organization, and juggling multiple tasks.

This position will be part of our Quality Control team, responsible for a variety of activities including incoming raw material inspection and release and Bulk Reagent/Assay Kit Inspection in accordance with current Good Manufacturing Practices (cGMPs).

This role spans a broad range of activities within the kitting team at Quanterix. In the role, process responsibilities include kitting, labeling and inventory activities to support a diverse assay menu.

Activation practitioner with experience in the media/search marketplace, who is eager to have immediate impact on RB E-Business team in its activation and optimization practice. Energized by the development of data architectures to drive performance along with executing dashboards that drive clear analysis and insights on in-market media results. Eager to create meaningful vendor partnerships & act as daily trader within self-service media platforms.

The Logistics Associate operates powered Lift Truck equipment to load, unload and move products, materials and equipment.  This position works as a fully participating and effective member of a “Self-Managed” Logistics Team responsible to deliver World Class results in the key areas of Quality, Safety, Customer Service and Cost.

The Associate Packaging Engineer is responsible for the package development of new and existing products to support launches and to improve gross margin. Design and develop packaging for existing products to support launches. Design and develop Customer Manufacturing offerings which include Warehouse Club and promotional SKUs. Aggressively drive and identify gross margin improvement projects through the optimization of primary and secondary package design / re-design.

The R&D Operations Assistant will work with technical product development on key projects for the R&D team.  Direct and conduct routine evaluation of existing commercial products, including performance and stability testing and claim support. Conduct evaluation of first production samples for new product launches, including performance and stability testing. Maintain appropriate level of communications with select Marketing and Supply personnel to accomplish objectives.

We are seeking a motivated, highly organized researcher to support our investigations of new antibody and cell-based therapies. Independently and as a team, conduct and support experiments. Investigating and develop new methodologies and technologies in molecular biology and biological therapeutics. Characterization of mice via NGS (next-generation sequencing) and flow cytometry-based phenotyping. Design, construct, and test DNA vectors, viral vectors, and cell-lines for in vitro and in vivo studies of candidate biologicals.

This role will primarily be involved in developing and executing state-of-the-art mass spectrometry and its related technologies for the analytical characterization (e.g., intact mass analysis and peptide mapping) of therapeutic proteins (e.g., monoclonal and bispecific antibodies) to support drug development activities at all stages (e.g., INDs, BLAs, comparability studies, stability studies, cell line development, process development, and formulation development), with a primary focus on supporting early stage drug candidate characterization and lead candidate selection.

Reporting to a Scientist/Senior Scientist, the Associate Scientist/Senior Associate Scientist will work on developing and optimizing novel cell culture processes for AAV production. Responsibilities may include routine cell culture, cell banking, process development, scale up, tech transfer for GMP production, data analysis, and authoring of technical reports and tech-transfer documents. Furthermore, this individual is expected to work independently on assigned tasks/projects, provide insight to improve processes, and communicate results in a timely manner.

The Manufacturing Coordinator supports the Process Supervisor in the daily activities of union and non-union personnel in the filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines.  Responsible for the proper operation of all production activities assigned such as scheduling and training.  This includes but is not limited to: preparing, staffing, and operating production line and safety. This is a swing shift position from 10:30 am to 7:00 pm.

This assembly position performs a wide variety of fiber assembly, filtration product assembly or sub-assemblies. Determines and/or follows methods and sequence of operations in performing fiber bundling, filter potting, filter welding, fitting on assembly units and packaging. The employee also works as a team member in whatever capacity and job function is required to deliver a quality product to our customer in a timely fashion.

On special assignment: assist in operational and logistical tasks of clinical trials, performed according to operational best practices and quality standards (ICH GCP/ Country and Local requirements/ Company SOPs). Provide support across the Clinical department.

This position is responsible for support to the quality team with task responsibility. This will involve modeling and detailing inspection prints, contributing individually and within cross-functional teams, and general project support. They will be a self-starter, have a hands-on approach in performing their work duties, and be able to work independently. This position will help RTI Surgical maximize the amount of patients served while maintaining a high level of quality and safety.   

Handle, transfer, and distribute mice, supplies and waste as needed to and from work area(s). Proficient in IM, IV, IP administration techniques in lab animals. Coordinate with vendors and supervisors on operational, administrative and technical responsibilities. Monitor the daily health and welfare of the animals according to IACUC guidelines

Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Manufacturing of Life Science products according to standard operating procedures and work instructions. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting

This position is located within the Quality Control department and is responsible for all programs release and stability testing, by performing analytical methods such as HPLC/ UPLC, Capillary Electrophoresis (CE), etc.

The Formulation and Drug Product Sciences Group at Seattle Genetics is seeking a highly motivated Research Associate to assist in the formulation development for therapeutic antibodies and antibody-drug conjugates. Conduct experiments and analyze results leading to development of robust formulations for antibodies and antibody drug conjugates

Responsible for receipt, storage, and delivery of laboratory supplies & equipment, office supplies and other products such as break room supplies. Shipping & Receiving Associates I must demonstrate meticulous attention to detail, flexibility and a willingness to perform a wide variety of tasks while adhering to defined procedures. The position will work directly with the Purchasing, Research & Development, and Finance departments to accurately track, record, deliver and maintain the correct amount of supplies and equipment to the correct locations at all times.

A Quality Control Technician works independently to provide quality control support of any area assigned where Sedia Biosciences is responsible for adhering to current Good Manufacturing Practices (cGMPs) for adherence to FDA regulations and applicable ISO standards including warehouse, manufacturing processes, inspection, labeling and packaging, batch record review/disposition, and new product design review and transfer activities. Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.

The successful candidate will be responsible for running laboratory tests, recording data, performing some degree of data analysis, drafting protocols, and communicating with managers from R&D and other departments. They will also be asked to participate in production of prototype products, and assist in transition of those procedures (through training and/or record-keeping) to our manufacturing department.

he full-time role will focus on tissue culture, molecular and cellular characterization, and assay development. Under the supervision of a Senior Scientist the associate will be responsible for the day-to-day execution of specific projects in coordination with members of the Process Development team.

This full-time role reports to the Director of Manufacturing, and will be responsible for the technology transfer and production of cell therapy products to support Semma’s Phase I/II clinical trials. Clinical materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA).

TE Energy business unit in Fuquay-Varina, North Carolina is seeking a Product Engineer to support both existing and new product development/improvement activities. The primary focus will be on the improvement and maintenance of existing system data (drawings, BOM’s, routings, product requirements, specifications, SWI’s, label templates, packaging requirements, etc.) necessary to the flawless operation of today’s ERP systems. However, this position interacts with every function within the company. Business acumen is fundamental. etc.

This positions requires basic CNC machining knowledge in order to produce machined parts to specification in an efficient and timely manner. This job requires skills to achieve metrics set forth within a specified work group or team. This is accomplished by maintaining Tecomet’s principles of Safety, Quality, Customer Satisfaction and Innovation. etc.

Responsible for kitting orders for Milling, Turning, and Swiss machining centers, providing all tooling, gaging, fixturing, vise jaws and material required to set up jobs, and staging kits before the start of a given job. PRINCIPAL DUTIES AND RESPONSIBILITES: Ensure shop paperwork is complete and accurate before starting kitting the job. Issue tooling from Robo Crib and set up necessary tools following machining set up sheets ensuring all tools are sharp and are in good condition. Issue gaging From Robo Crib using in process and FAI paperwork. etc.

The Production Technician position performs all tasks involved in the pharmaceutical process following cGMP’s and SOP’s such as wet granulation, dry granulation, tablet compression, encapsulation, tablet coating, packaging and finished product, put product on stability. The position follows standard work methods and practices safe work habits to ensure production is as efficient and safe as possible. etc.

Assist with providing high quality analytical method development and validation in a GMP environment. Support new product development through analysis of innovator samples and R&D formulations. Essential Responsibilities: Participate in the development and validation of analytical methods and improvement of existing ones to support all stages of drug development from drug substance characterization through formulations and process development and ANDA submission of oral and topical products. etc.

Responsibilities: Building and maintaining relationships with physicians and office staff to drive clinical orders in the community. Building and maintaining relationships with pathology departments to ensure smooth specimen sendouts - tissue procurement. Maintain a regular cadence of touch points (in person, emailing value adds) with certain targeted accounts (ie 3 x month per physician). etc.

Responsibilities: Building and maintaining relationships with physicians and office staff to drive clinical orders in the community. Building and maintaining relationships with pathology departments to ensure smooth specimen sendouts - tissue procurement. Maintain a regular cadence of touch points (in person, emailing value adds) with certain targeted accounts (ie 3 x month per physician). etc.

Key Responsibilities: Maintain human iPSC cultures and differentiate to cells of the cardiovascular lineage. Perform a diverse range of cell-based assays to discover and characterize lead therapeutic molecules for heart failure. Oversee aspects of maintaining the cell culture lab, including preparing reagents, helping with room upkeep, and restocking. Execute a range of experiments using molecular biology techniques including plasmid design, nucleic acid and protein isolation, PCR, cloning, virus preparation, and immune assays. Generate SOP protocols when required for new procedures. Regularly present scientific findings in internal scientific discussions and meetings.

We are seeking a Junior Technical Support Specialist with an understanding of Healthcare IT systems and basic computer hardware software knowledge. Responsibilities: Provide first line of technical support to customers via phone, email or chat utilizing remote access tools provided by TeraRecon. Analyze and resolve basic customer service issues associated with TeraRecon products running on Windows Workstations and Windows Server Operating Systems. Prompt escalation of customer product issues in a timely manner for analysis and further action by higher level of support. etc.

Job Purpose: This laboratory-based position will support the analysis of semi-solid drug products, with a focus on performing Skin permeation/IVPT experiments. Summary of Key Responsibilities: Conduct routine analytical experiments using established skin permeation methods and procedures. Troubleshoot and maintain analytical instrumentation for maximizing uptime. Coordinate instrumentation to facilitate maximum use of existing equipment. Maintain a GxP-compliant analytical laboratory and safe laboratory working environment.

Job Summary: The NPD Test & Evaluation Test Technician position is responsible for the preparation and testing of pre-production devices to support the product development process. The position is also responsible for testing support of competitor product evaluations for marketing information. Assisting in preparing the lab for simulated clinical evaluations and new product pilot lines is also included in the position. An additional responsibility is supporting the acquisition, calibration and validation of lab equipment. Job Details: 1. Associate is responsible to follow requirements of TMC Quality System; including but not limited to: document/data control, compliance with procedures, and change control practices. 2. Perform basic product testing on prototype, pre-production, and/ or final design products. etc.

Job Summary: Performs manual and/or repetitive job duties which may include inspecting, packing, and assembling of product. Job Details: 1. Manually pack product into proper shelf packs/cases/shippers/bags, etc. 2. Ability to inspect both visually and functional aspects of product. 3. Ability to assemble product as required; may need use of hand tools. 4. May include some equipment operation. etc.

Under general supervision, the Pharm Tech Specialist I determines the critical aspects of manufacturing equipment with regard to product and process, and writes protocols and other records related test results. Prepares final reports that identify the results of protocol testing and the conditions of release. Assists in conducting efficiency studies and in the identification of process improvement opportunities. Participates in project coordination activities. etc.

Supports general office receptionist duties to include performing administrative office-support service tasks. Responsible for properly answering and routing incoming calls and performs general business office operations by providing various administrative support activities as a generalist or in a combination of the Disciplines in Administrative Services Function. Must have prior incoming call center service, receptionist or office assistance experience. Entry to mid-level role acquiring basic administrative skills required to perform day-to-day operations. Self-starter, who is capable of working well independently with minimal supervision. Good communication skills, both written and verbal. Strong attention to detail. Professional demeanor. etc.

The AR Specialist on the Cash & Manual Transactions Team is responsible for providing financial, administrative and transactional processing services and expertise to ensure effective, efficient and accurate financial and administrative operations for multiple operating units within the Global Teva organization. The Accounts Receivable Specialist is a key support person for the department who can meet deadlines, manage workload based on critical needs, and be able to provide extensive support across a variety of areas. Due to business fluctuations, the below duties and responsibilities can be shared or done exclusively by a given individual with this position title. The AR Specialist must work within established policies and procedures in compliance of SOX regulation. etc.

Under general supervision, performs cGMP laboratory analyses of Finished products and in process materials. Performs stability testing for Finished products. Performs maintenance and calibration of analytical instruments. Essential Functions Include: Carries out responsibilities in accordance with the organization’s policies, procedures and state, federal and local laws. Operates general analytical instruments during the testing of finished products using HPLC, UPLC, GC-FID, UV-VIS, FTIR, automatic titrators, Dissolution Apparatus, particle size analyzer, Instron, Densitometer, Rheometer, viscometer (LV/RV/Cone and Plate), pH meter and analytical balance. etc.

The Assembly Technician will perform basic assembly operations for medical device assembly of a variety of suture products in a clean room environment. Essential Duties and Responsibilities: Set up the work station for each new production lot. Perform machine operations for surgical suture assembly according to standard operating procedures, specifications and work instructions. Follow quality and safety procedures. etc.

Prepare reagent/standard in accordance with ACS, USP and other outlined company procedures. Key Responsibilities: Responsible to keep lab area clean in accordance with 5S/housekeeping standards. Wash glassware as needed to minimize dirty glassware in the lab. Coordinate with outside labs to ensure prompt delivery of results. Responsible to check operation, function and calibration of lab equipment. Conduct verification of equipment such as pH meter, balances on daily basis. Ensure lab has required reagent, chemical and standard that are within expiration date.

Entry level position into the Packaging/ Labeling department. The associate will develop mandatory skills for continued employment at Thermo Fisher. These skills include learning paperwork, basic packaging/ labeling skills, and demonstration of an excellent work ethic, ability to grow with the team, communication skills, and ability to follow direction. Excelling in this position will allow for upward mobility within the department. etc.

Under general supervision, develops the packaging components and packaging requirements for existing commercial products and for development projects. Develops, maintains and monitors packaging components to ensure compliance with Quality, Safety, Manufacturing and Regulatory guidelines and procedures. Conducts testing activities that influence selection of primary, secondary and tertiary packaging components. Essential Duties & Responsibilities: Work with project team to identify, select, and test primary, secondary and tertiary packaging components. etc.

The Validation Engineer is responsible for qualifying cGMP manufacturing equipment cleaning, process validation, and aseptic/sterile processes. Generates qualification protocol(s), for various processes in the facility. Oversees the timely completion of all validation documentation, including coordination of contractor activities. Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable.

The Associate Scientist/Engineer I/II is actively engaged in process and product development within a dynamic team and displays strong technical knowledge, initiative, and scientific commitment, and makes significant scientific and technical contributions to downstream process development. Integral team member in moving projects forward toward GMP Manufacturing for clinical trials, registration, improvements of existing processes and products

Establish and evaluate all PCBA manufacturing processes, including Surface Mount Technology and Wave Soldering. Established understanding of printed circuit assembly processes including: solder paste printing, placement, reflow profiling of thermal characteristics, automated inspection parameters, IPC 610 F acceptability requirements.

The R&D Scientist is responsible for the hands-on development of immunoassays, such as ELISAs and cell-based assays, for commercial production. This individual plans and executes design, development, and Manufacturing transfer of bioanalytical assays for product commercialization. The R&D Scientist is also responsible for development of custom assays and reagents for clients.

To ensure the quality of PBL reagents the Quality Control (QC) Scientist I will perform release and stability testing of interferons, antibodies, and manufactured ELISA kits. In addition, the QC Scientist I will perform bioassays or immunoassays to troubleshoot relevant customer issues and design and initiate experiments and projects to improve the quality of PBL products. The QC Scientist I may also serve as back up to the Product Development, Assay Services, or Manufacturing departments as needed: such additional duties may include designing and performing ELISA testing protocols, custom bioassays, and solution preparation. This individual will be involved with document control, SOP writing, and recordkeeping.

Design packages, processes, and tooling to package pharmaceutical products in a consistent high quality package which complies with cGMP's and customer requirements.

Support implementation of ERP system by perfoming data scrubbing and conversion efforts. Extract, map, and transform data to meet ERP migration requirements.

Working with Business Development Executives, provides high quality clinical packaging and distribution proposals within expected timeframe. Based on quote requirements, works with various internal departments to calculate complex costing in order to deliver Proposals and Change Orders to customer's right first time. Prepares and presents proposals to Business Development Executives and customers during customer facing meetings when applicable.

As a Quality Control Inspector, you will test and inspect components and products in the laboratory. Perform routine inspection at incoming Quality Control and finished device level. Inspect components, products, labels, boxes, pouches, and coatings visually and mechanically. Take measurements using micrometers, calipers, snap gages, gage pins and other measuring instruments.

As an Engineer I at Penumbra, you will work with engineers in the Manufacturing, Research and Development, or Quality groups to support the development and testing of new products; the development and improvement of manufacturing processes; and compliance with Penumbra’s Quality System and all applicable regulations and standards. 

Perform lab experiments as planned and document all observations and findings. Prepare hybridization capture NGS libraries and amplicon panel NGS libraries. Analyze and interpret data. Present experimental findings and interpretations to senior research team members. Demonstrate potential for technical proficiency and ability to collaborate with others.

As a QC Chemist, you will perform analytical testing on samples relative to the release of Perrigo materials and product according to cGMP requirements. Collect samples including raw material, finished product, process equipment and environmental. Test purchased materials and/or Perrigo manufactured products per cGMP requirements and participate in laboratory investigations.

To ensure the Quality and Compliance of raw materials, finished products, and stability samples by performing laboratory analytical testing relative to the support of Perrigo operations and manufacturing needs. Responsible for preparing solutions and reagents for testing as required.   Uses analytical laboratory equipment such as HPLC, UPLC, GC, UV and IR. Works independently and within team under direction of supervisor to accomplish tasks.

This position will share specialized knowledge with management in the development and implementation of on-going processes or special projects, and recommend process changes to eliminate repetitive problems.  Participate in capacity or budget planning, gather and evaluate information, and make/present recommendations.  May test or evaluate materials or process changes and recommend their implementation or rejection, supervise on-going or special maintenance or installation projects, and work with engineering staff to select or evaluate new equipment both on capital projects and ancillary equipment.

This role is responsible for delivering value, including year on year cost savings, within the Indirect categories within Market/Site, across all Business Unit’s and Divisions as applicable. The buyer role provides operational support to the procurement team, including data analysis and reporting, market intelligence gathering, and project tracking. This role also acts as a liaison with Category Strategy Managers (CSM) to support the execution of Market/Site, and where agreed, Regional category strategies through participation on cross-functional teams

Reporting to the Supervisor of Engineering, the Facilities Technician will be responsible for PMI’s maintenance and equipment support activities. The Facilities Technician performs with minimal supervision preventive maintenance, demand maintenance and calibration tasks on critical equipment, utilities, and facilities.  

The Chemist I position, reporting to the Director, Analytical Development, will operate under moderate supervision to perform chemical analyses of samples according to standardized procedures to determine the identity, content, purity, stability, and other characteristics of the samples analyzed. He/she may perform method development activities related to the development of methods for testing of raw materials and clinical drug product as well as formulation development.

Provides line-level management coordination of resources and work schedules for laboratory activities. Oversees daily operations and assists in preparation and implementation of company policies, quality systems and training programs. Ensures that projects are completed in a timely manner so that company revenues are met and clients are satisfied with the quality and turnaround time of work being performed.

The basic purpose of the Quality Assurance (QA) Auditor is to assure the quality of laboratory data and reports.  This is accomplished by reviewing data and reports as specified by SOP's (Standard Operating Procedures), and by conducting project specific audits of laboratory procedures and by writing audit reports. 

The Associate Process Engineer works within the Cell Therapy Development team and will participate in process development efforts, delivering best-in-class manufacturing methods for allogeneic T cell therapies. The position will assist in the clinical progression of candidate CAR and TCR T cell therapies by designing and executing process development experiments across a variety of process scales. The Associate Process Engineer will collaborate internally across functional areas as well as externally with industry partners to ensure project advancement, rapid and best-in-class execution, and effective communication of challenges and opportunities.

The Proposal Associate works closely with a cross-functional team to provide responses to laboratory services RFPs and RFIs from government and commercial clients. You will support the proposal process from receipt of RFP through submission and pipeline tracking. Typical duties include attending proposal development meetings, tracking proposal statuses, assisting with developing pricing and text for proposals and quotes, crafting and distributing reports, and tracking opportunities in Salesforce.com.

Authoring and reviewing statistical analysis plans, including development of table and listing shells. Providing input into development of case report forms (CRFs). Generating randomization schedules and providing sample size calculations. Generating analysis datasets, tables, figures, and listings to support the analysis of clinical trials data using SAS.

We are looking for a full-time Vivarium Assistant to perform husbandry tasks such as thechanging and cleaning of animal cages, feeding/watering of animals, and the sanitation/ cleaning of the animal facility.

This position is responsible for performing pharmaceutical related functions in compliance with state and federal regulations, protocol specific requirements, and the Company’s values, policies, and procedures under the direction of the Pharmaceutical Services Supervisor. Receive, label, store, organize, and return/destroy study medications for clinical trials. Prepare and update all drug inventory logs and ensure logs are current with all clinical trial drug preparation schedules.

Mission Pharmacal Company, a pharmaceutical manufacturing company, is seeking an energetic Product Handler Trainee to join our team in Boerne, TX. Responsibilities include performing assembly/production, warehouse/receiving, distribution or manufacturing functions.

The primary purpose of this Manufacturing Associate position is to perform manufacturing support functions. This role will require the ability to review Manufacturing DHR and perform in process quality checks throughout the day at various manufacturing lines. This includes reconciliation, kitting verification, labor collection, and coordination of scheduled activities with the Manufacturing Manager or as direction from the Manufacturing Team Leader. This position is dedicated to maintaining compliance in the manufacturing area.

This individual executes scale-up studies from pilot through full clinical and commercial scale and interacts extensively with downstream Process Development, Analytical Development and Manufacturing personnel to deliver high-quality and robust upstream processes in a regulated environment.  

You will be doing: Building native mobile apps leveraging cross platform technologies. Utilizing Swift, Kotlin, C#/.NET & Cloud platforms. Iterating on design and functionality with our Product Managers and designers. Working closely with a team of mobile developers, testers, product managers. Able to jointly and independently make decisions, define required changes, and communicate modifications to the entire project team.

The Marketing Associate is responsible for sales support initiatives, including the development of new marketing materials, maintenance of existing materials and the overall enhancement of HCS marketing communications. This individual will need to understand and drive the Healthcare Systems brand as well as develop creative marketing templates, ensuring consistency in materials. Provides sales support to Corporate, National and Government Accounts teams by fielding questions, aiding in customer presentation development, gathering specific information from business unit marketing teams and maintaining price files. etc.

Assembles mechanical units, fabricated parts/components and/or electrical/electronic systems to make subassemblies, assemblies or complete units using hand tools, power tools, jigs, fixtures and miscellaneous equipment. Fits, aligns, calibrates and adjusts parts and mechanisms to meet tolerances and product operating requirements; repairing units or products that have failed to meet requirements.

Provides customer services relating to sales, sales promotions, installations and communications. Ensures that good customer relations are maintained and customer claims and complaints are resolved fairly, effectively and in accordance with the consumer laws. Develops organization-wide initiatives to proactively inform and educate customers. Develops improvement plans in response to customer surveys. etc.

As an Interventional Spine Associate Sales Representative, you assist in strategically promoting and selling Stryker IVS products to meet our customers’ needs. You confidently conduct product evaluations in Operating Room and office settings, persuasively demonstrating the value of our products. Systematically tracking your territory progress, you proactively communicate your findings with your Regional Manager and Sales Representative(s) you are supporting to push yourself to exceed each goal. When onsite with clients, you use your product knowledge and quick thinking to solve product problems and inform doctors, nurses and other staff as to the proper use and maintenance of our products. You take great pride in meticulously managing and maintaining your sample inventory of products and are prepared to assist a customer whenever the need arises. etc.

Your main responsibilities will be to perform functions in support of Product Application Scientist(s) and other individuals as needed, perform common laboratory testing (including ELISA) using established protocols, prepare buffers and other chemical solutions as needed and use proper personal protective equipment (PPE) and good aseptic technique to handle biological (including human) samples. On a day-to-day basis, you will be expected tosuggest, plan and carry out studies with guidance of supervisor, record data for evaluation, analyze results with guidance of supervisor and assist other lab personnel as needed, maintain organized records of studies performed, and other duties and responsibilities as assigned.

The Statistical Analyst will work with a small team led by the Director, Analytics, Programs and Insights. This Analysis Group provides vital support to all other key functions of the company: research and development, marketing, finance, and operations. Team members analyze patient compliance programs, form hypotheses, dissect patient data, evaluate program performance, and explore trends. The Analyst will be responsible for generating and analyzing reports for management and pharmaceutical clients. Specific responsibilities include running analytical reports in SAS and Excel, assisting in the development of methodology, and collaborating with analytics directors.

This opportunity is with our Selling Solutions Commercial Division, which partners with top tier pharmaceutical, medical device and biotechnology companies to develop and execute sales and marketing strategies that deliver. The selected professional will be an integral part of a nationwide sales team developing and managing an assigned territory. You will: Maximize new business opportunities with physicians and other health service providers. Present therapeutic products and creatively teach people about their usage. Engage in meaningful dialogue that addresses the needs of the health provider and patient. Build trust and credibility and become a true collaborator in commercial success.

Assists the Clinical Research Coordinators in their responsibilities by doing the following: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Assists the Clinical Research Coordinators with updating and maintaining logs and filing in charts; Schedules subjects for study visits and conducts appointment reminders; etc.

Research Assistant - Pre-clinical will be trained to provide technical support to the senior scientist on a defined project from conception to proof-of-concept in vitro and in vivo. What You'll Do: Process leukopacks and bone marrow to isolate primary cell culture (ie - stem cells and T cells) depending on the project. Maintain and expand primary cells. Test conditions to optimize gene editing of specific cell type. Vector cloning and various molecular biology assays as needed. Viral production. Assist in tissue processing and analyses. etc.

We are seeking a highly motivated junior scientist to join our high-throughput biology operations team. You’ll work with a team of scientists and engineers on these responsibilities and more: Culturing iPSCs. Differentiating iPSCs into neurons. Imaging cells using fluorescent imaging systems. Manipulating cells via transfections, dyes, or viruses. Troubleshooting experiments. Maintain a safe and orderly working environment. etc.

We are looking for a Services Technician to join our Germantown location. This position will be part time, with the following schedule: Friday Mornings - 4 hours, Saturday Mornings - 4 hours, and Sundays - 8 hours. Service Technicians are responsible for animal husbandry – caring for laboratory animals (mice and/or rats) in designated areas. These individuals ensure that high standards of animal welfare are met, and that the animals are fed, clean, and cared for. Service Technicians are also responsible for assisting with the breeding of animals and performing biopsies as necessary, as well as maintain accurate inventory records. etc.

The research associate will join a fast-paced Biotherapeutic Engineering team within Global Biologics Research. The candidate will perform complex research assignments and will be responsible for the discovery and engineering of therapeutic biologics including antibodies, fusions and other platforms. The candidate will communicate results within the Biotherapeutic Engineering team and with cross functional project team members. ACCOUNTABILITIES: Under minimal supervision, execute discovery and lead optimization projects using display platform technologies with high quality and efficiency. etc.

The candidate will join the Assay Development group in the R&D division where focus is on molecular assays development such as nucleic acid isolation, purification, amplification and labeling technologies. We are seeking talented, motivated individuals to join a collaborative effort to enable development of rapid diagnostic tests of several pathogens from various clinical specimens. Position Responsibilities: Work with senior scientists and run hands-on experiments for microbiology, sample preparation, nucleic acid extraction and amplification. Participate in design of molecular assays. etc.

The Research Associate will perform analytical tests using HPLC, Spectrophotometry (RP, IEX, SEC, HILIC etc.), CE, mass with high quality and efficiency; provides analytical support in R&D settings for samples from various process scales; writes experiment summaries and development reports; and assists during document review comprising of but not limited to: batch records, standard operating procedures and assay protocols. etc.

Responsibilities: Supports the clinical study teams in the execution and delivery of studies. Organizes, manages, and oversees the Trial Master File to maintain up-to-date regulatory documentation for all research sites. Responsible for study laboratory sample management, including tracking and vendor management support. Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders. etc.

This position requires a person to perform simple set ups and operate manual/CNC equipment to manufacture medical components from raw material in a team based environment. Must be able to comply with all governing rules including S.N.E. policies and procedures and adhere to safety and cleanliness practices in the work place. This position works under close supervision. Essential Duties And Responsibilities: Machine medical components, including but not limited to: Perform simple set ups and operate manual/CNC equipment, including turning, milling, grinding, drilling, tapping, EDM and honing. etc.

What you’ll do: You will support Account Manager(s) to address the business needs and goals within the district or region, promoting key brands such as Grafix™ within acute care facilities. You will act as the Account Manager in open territories needing coverage. You will use your organizational skills to coordinate availability of products for hospital outpatient departments. You will use your knowledge and expertise to provide in services to appropriate personnel and to educate end users on the clinical benefits of products. etc.

The Quality Assurance Inspector 1 shall be responsible for performing basic visual/dimensional/functional inspections of incoming purchased product as well as product manufactured/assembled in-house, determining whether or not product meets specifications and documenting these decisions. RESPONSIBILITES: Inspect raw materials, components, assembled product, semi-finished product & finished product per inspection procedures/drawings and to print specifications. Utilize attribute and variable measuring equipment/gauges as well as mating parts to determine as found/as left conditions of product. etc.

The Team Technician is responsible for ensuring the correct operation of automatic and semi-automatic assembly production equipment in accordance with governing documentation. This person will also initiate action to prevent the occurrence of nonconformances related to the product and equipment. Additionally, this role will identify and record problems relating to the product, process and or quality system. The Team Technician will also initiate recommendations, provide solutions, and verify the affectivity of continuous operational improvements. etc.

Duties & Responsibilities: Demonstrate leadership and accountability in providing and sustaining a positive safety culture. Provide support for safety training, meetings, and programs. Ensure proper instruction is provided on responsibilities and safe job performance (on the job training). Provide support for safety training, meetings, and programs. Attend passdown meetings, noting key quality and output issues. Observe and communicate out of the ordinary situations and ensure issues are resolved. Collect performance sheets at the end of the shift and give them to the Production Supervisor for entry in the passdown document. Make decisions of priority and value added impacts with regards to safety, quality, customers, and efficiencies. etc.

MAIN JOB RESPONSIBILITIES / COMPETENCIES: Support site production, operations, and quality and R&D teams by addressing emergent issues that might arise due to the operation processes. Serve as the quality representative during any product or process investigation. Lead investigations including root cause analysis and health risk assessment of the identified product or process nonconformities. Prepare and execute validations, technical studies, test method validations and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports. Initiate and lead project teams on non-conformance investigations regarding component failures, finished goods failures, and product returns. This includes but is not limited to performing risk analysis, determining root cause and recommending corrective action. etc.

MAIN JOB RESPONSIBILITIES / COMPETENCIES: Plan, prepare and review all aspects of ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports. Review/Prepare Standard Operating Procedures (SOPs). Compile information necessary for periodic reports for Regulatory filings. Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing. etc.

Starkey Hearing Technologies is seeking to add a Retail Digital Marketing Associate - Content. This person is responsible for supporting the Retail Digital Marketing teams with development and maintenance of our customer website programs. This position will collaborate with the Retail Digital Marketing Strategist on the execution and reporting of campaigns across all digital channels. The Retail Digital Marketing Associate will make regular website updates and make recommendations on how to improve website performance, user experience and lead performance. etc.

We are seeking to add a Sales Operations Associate that will execute a wide range of sales operations tasks and projects aimed at improving the efficiency and effectiveness of the sales team. Other duties and tasks come with this role and will be added regularly to support the changing needs of the sales team and sales leadership. etc.

Are you interested in Facebook advertising and lead acquisition? Do you want to be a part of a company that seeks to help people improve their lives? We are seeking a Facebook advertising professional/specialist/coordinator to join a strong team focused on paid acquisition efforts, and to ultimately build and grow our marketing initiatives to meet business goals. The ideal candidate has strong interest in Facebook advertising and is willing to roll up their sleeves to get involved with the detailed execution of initiatives. etc.

Supports lead biostatistician on clinical studies; may serve as lead biostatistician with oversight from a more senior biostatistician. Maintains the statistical integrity of clinical trials analyzed by SDC. Assists in preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, and writing statistical sections of clinical study reports. Primary Responsibilities: Assist in writing statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed. Review CRFs to ensure consistency with protocol and adequacy in collecting data to meet objectives and statistical analyses defined in the protocol. etc.

Provide on site and remote service and support of Stereotaxis magnetic navigation systems including permanent magnets, and servo control systems. Interface with customers and vendors to ensure a quality service experience and that all expectations are met. ESSENTIAL JOB RESPONSIBILITIES: Interface with customers to obtain accurate details of the equipment service needs and provide updates regarding the progress of the service/installation. Diagnose and repair control servo control systems. etc.

This position is responsible for the maintenance and efficient operation of production/manufacturing equipment for pharmaceutical operations. Position also responsible to perform both maintenance and preventative maintenance, and repair work to production equipment as needed. Provides troubleshooting on rudimentary issues and seeks guidance as part of an escalation process. etc.

This position is responsible for performing/controlling a combination of manual or automated tasks necessary for the receipt, storage, and shipment of product. This may include functions of receiving, picking, packing, shipping, staging, transporting, storage, delivery, etc. You will: Loads and or unload materials using proper methods and procedures for securing materials. Receives, selects and prepares materials for relocation to end users. Ensures accuracy of shipments and supporting documentation, receiving incoming material and routing to appropriate area or personnel, filling work orders, packaging assemblies and receiving into finished goods, ensuring inventory transaction are accurately logged and overseeing cycle counts and reconciliation activities. etc.

The primary role of the Repair Technician is to perform repairs on medical instrumentation. Technicians will be trained to become familiar with various types of surgical instruments and understand how to best maintain and repair them. Repairs are completed on a repair truck onsite at a hospital or surgery center. In addition to repair work, Technicians may work with a team including Sales Representatives and RCs (Repair Consultants/Managers) to identify and capitalize on revenue opportunities. Travel requirements may vary by location. etc.

Coordination and oversight of daily activities between the OR and Sterile Processing Department (SPD) to facilitate efficient case flow. Responsible for assisting in projects and process improvement initiatives in compliance with contractual obligations. Promotes customer service/satisfaction through training, education, and resolution of OR frictions for the facility. Perform duties in accordance with hospital, TJC, AORN, AAMI and other appropriate policies and procedures. This is a full-time position (non-contract) that provides benefits, paid time off and paid holidays. 75-100% travel. etc.

The Operating Room Liaison individual will work to coordinate and have oversight of daily activities between the Operating Room (OR) and Sterile Processing Department (SPD) to facilitate efficient case flow. Responsible for assisting in projects and process improvement initiatives in compliance with contractual obligations. Promotes customer service/satisfaction through training, education, and resolution of OR frictions for the facility. Perform duties in accordance with hospital, TJC, AORN, AAMI and other appropriate policies and procedures. etc.

The primary role of the Repair Technician is to perform repairs on medical instrumentation. Technicians will be trained to become familiar with various types of surgical instruments and understand how to best maintain and repair them. Repairs are completed on a repair truck onsite at a hospital or surgery center. In addition to repair work, Technicians may work with a team including Sales Representatives and RCs (Repair Consultants/Managers) to identify and capitalize on revenue opportunities. Travel requirements may vary by location. etc.

Technical activities include projects leading to product improvement.  You will also contribute on several levels including: Contribute documentation for support of project Design History Files. Gain cadaver lab/OR experience – support Surgeon training. Interface effectively with suppliers and become educated on manufacturing methods and capabilities. Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485

The Associate Distribution Coordinator initiates, maintains, and compiles records associated with ordering, receiving, storing, issuing, and shipping materials, supplies, and equipment by performing the following duties: Compares nomenclature, stock numbers, and other listed information on packing slips to verify the accuracy of purchase orders and shipping orders. Compiles data from sources such as contracts, purchase orders, invoices, requisitions, and accounting reports and writes, types, or enters information into computer to maintain inventory, purchasing, shipping, and other records. Compiles and maintains manual or computerized records such as material inventory, in-process production reports, and status of material locations

Technical activities include projects leading to product improvement.  You will also contribute on several levels including: Contribute documentation for support of project Design History Files. Gain cadaver lab/OR experience – support Surgeon training. Interface effectively with suppliers and become educated on manufacturing methods and capabilities. Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485

The Downstream Pilot Plant Technician I reports to Downstream Pilot Plant Manager and performs method development, product and process development, scale up/scale down processing and purification, performing a wide variety of activities including but not limited to the following: Basic cell and tissue culture of prokaryotic and eukaryotic systems. Expression and purification of recombinant proteins using a variety of expression systems. General analytical chemistry, protein biochemistry and molecular biology methods such as liquid chromatography (HPLC, FPLC and low pressure systems), gel electrophoresis, western blotting, ELISA, PCR, protein assays, enzyme/bioactivity assays and bioinformatics.

The Transducer Design Engineer performs engineering design, development, and maintenance tasks, and assist in various phases of ongoing projects. He / She works with a dynamic team of product managers, mechanical, acoustical and manufacturing engineers to improve existing and create new best-in-class single-element and phased array probes. The incumbent's work includes concept generation, CAD layouts, detail design, fixture design and testing.

The Associate Imaging Representative (confocal) functions as a resource for the customer. Identify customer needs based upon detailed discussions. Using product and application knowledge, provide solutions to meet their imaging and system needs. Install and train customer using equipment purchased.

The Regulatory Affairs Analyst I is responsible for the review and investigation of medical device complaints. The incumebent coordinates the resolution of complaints and ensures that timely investigations are performed. He/She prepares and files Medical Device Report (MDR) for Medical Systems Group (MSG) products. The RA Analyst I maintains quality documents to ensure compliance with FDA regulations and guidance documents relating to these areas of responsibility. The incumbent functions as part of MSGs Regulatory Affairs team, in fulfillment of corporate objectives for FDA regulatory compliance. He/She requires general instruction for routine assignments, from Supervisor and/or more experienced staff.

By supporting the Product Quality function within CMD, you will help us achieve product quality improvement goals ultimately leading to increased customer satisfaction and product margins. Primary responsibilities will be improving data quality & reporting formats, developing quality checks to ensure correct reporting, and creating dashboards supporting all product quality metrics. Additionally, this role will support any data analyses required by CMD Product Quality Team.

Sets-up, operates, and maintains the classified environments and manufacturing equipment for pharmaceutical products. Requires proficiency in; cleaning and sterilizing equipment, gowning and aseptic techniques, preparing equipment and components for operations, operating and troubleshooting mechanical equipment, following approved procedures and proper documentation.

The Digital Science group of Thermo Fisher Science, located in Branford, Connecticut is seeking a highly-motivated individual who will be participating in all phases of product development in our mission to build a large, distributed web-based platform that scales and adapts to a variety of scientific, medical, and laboratory needs. Codes software applications to adhere to designs supporting internal business requirements and external customers. Design, build, and maintain efficient, well designed, and testable code

Maintains cleanliness required of equipment, work areas, and facility with assistance of assigned personnel. Prepares manufacturing suites and components for Production Batch Record execution. Performs cleaning of the cGMP suites. Executes Production Batch Records. Executes Work Orders. Keeps proper Personal Protective Equipment (PPE) and gowning materials supplied in gowning suite. Maintains cGMP materials inventory according to applicable Standard Operating Procedures (SOP’s). Complies with established waste disposal operations.

Manufacturing Technician I is responsible for completing and assisting with daily tasks associated with cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Additionally, the Technician I will be responsible for following SOPs, performing daily tasks in a clean room/cGMP environment per the current QSRs. The Manufacturing Technician I may also be responsible for the troubleshooting of manufacturing challenges

The Manufacturing Technician I - TCS is responsible for completing and assisting with daily tasks associated with support related functions for TC including assembly and sterilization of sub-assembly items, material management and manufacturing final product for commercial distribution. Responsible for following SOPs, performing daily tasks in a clean room/cGMP environment per the current QSRs. May also be responsible for troubleshooting manufacturing product challenges. Follows established company rules, regulations and safety precautions, and maintains quality standards

The Production Associate I - Collagen performs activities involved in the production of Collagen  These activities include, but are not limited to, protein purifications, filtrations, and titrations in the production of high quality, purified, sterile collagen for both internal and external customers.  This position requires working in a regulated area under the direct supervision of a team leader or departmental supervisor. 

Involves multiple de novo R/D projects for antibodyand assay products development.Performsvalidation tests on variant sera or antibody samples. Participates other duties such as antibody production, purification and conjugation. Strong organizational skills and possess strong ability to identify, analyze and solve the problems independently.

Working under the direction of senior marketing personnel, the individual will initiate, coordinate and / or execute a wide variety of marketing tasks to help drive adoption and education of the Global Spine product lines. Execute strategic and tactical plans to support market growth of the Global Spine products. Collaborate with the Events Planning team to coordinate and manage Global Spine trade show activities. Develop and maintain Global Spine engagement on social media channels such as LinkedIn, Facebook, Twitter and YouTube, and identify new opportunities where Global Spine should interact in the future.

The Validation Engineer is responsible for supporting validation activities pertaining to new and existing cGMP systems including process equipment, utilities, cleaning, and computer systems according to current Good Manufacturing Practices (cGMP). The validation activities will include but are not limited to measuring, analyzing, and calibrating equipment and processes to ensure all cGMP systems and equipment are operating according to the predefined specifications and the output of the systems or equipment are consistently and reliably meeting the needs of the user.

The Packaging Process Technician will provide quality oversight to the packaging processes and functions during the inspection and cartoning of commercial product lots.  Direct support and oversight will be provided to internal departments to ensure compliance of cGMP standards and FDA regulations.  Additionally, the Packaging Process Technician will perform real time review and approval of PBRs and supporting documentation accompanying the packaging processes and work with appropriate Line leads/Supervisors to ensure documentation errors or issues are resolved.

As a member of the Lentigen Technology team, you will have the opportunity to perform duties within the area of infectious disease research and development. This includes genetic manipulation of viral vectors, immune cells and working with live HIV-1 as it relates to HIV Immunotherapy.  Furthermore, you will be responsible for designing specific experiments relevant to HIV Immunotherapy and analyzing the data using appropriate statistical methods.

As a member of the Miltenyi Biotec Manufacturing team, you will have the exciting opportunity to participate in both the manufacture and process development of T-cells and multiple other cell therapy products within a GMP environment. The unique duties of this position will primarily consist of manufacturing primary human cells including activities that involve graft engineering for cellular therapies as well as supporting the development of scalable cell culture processes.

As a key member of the Miltenyi Biotec Accounting team, you will provide accounts payable and accounts receivable support including collecting and posting payments, assisting in debits and credits when needed, reconciling back-up documents to invoices, processing invoices through receipt and account verification, maintaining vendor and accounting files, and preparing and verifying bank deposits. Within this role, you will perform month end duties as required inclusive of GL review and journal entries, as well as providing general administrative support.

Perform expression and purification of antibodies, Fc-fusion proteins and recombinant proteins. Perform basic protein QC to determine purity and homogeneity. Conduct protein characterization in binding, polyreactivity and chemical/physical stability studies. Thoroughly document experiments and communicate results across Program Teams. Present scientific data within and across Program Teams

The Quality Associate I, Operations is responsible for actively participating in “on the floor” Quality activities during product manufacturing and/or packaging. Quality activities include product sampling and inspection, area clearance to confirm process readiness, and non-conforming event support to resolve in-process issues. Identifies and escalates issues or problems to appropriate supervision.

The Manufacturing Operator I performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs).  Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing.  Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput and quality.  Learns, understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward.

Principle duties/responsibilities include: May perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs and work instructions. Accurately collects and records raw data in logbooks and on worksheets. May be responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures. May be required to perform personal gowning environmental testing, and submit organisms from gowning, environmental and sterility test positives for identification and inclusion in monthly trending data, as required for specific testing as applicable.

Primarily involved in the welfare and husbandry activities of animals, including sanitation of equipment and the vivarium. Receives, identifies, and acclimates laboratory animals. Follows the Quality Manual, all NAMSA SOPs, and Process documents. Documents all required tasks. May administer treatments as directed by staff veterinarian.

The Manufacturing Research Associate I is responsible for supporting the production of reagents used in nCounter Analysis Systems. The role requires learning and performing both manual and automated production processes for the manufacture of raw, intermediate, and final reagents needed for the multiplexed detection and quantification of many different types of target molecules from biological samples. This individual learns to use professional concepts and apply company policies and procedures to resolve routine issues, in addition to acquiring the skills to use equipment, perform SOPs, use Document Control systems, ERP systems, etc.

The Research Associate (Cell Culture Technician) will assist scientist/senior research associate for the culturing, plating, distribution, maintenance, and banking of cell culture lines. Important aspects of this role include excellent organization skills, flexibility, and the ability to thrive in an efficient, highly interactive, goal-oriented team environment, and working with minimal supervision. As a team member of the cell culture group you will work to support cell and tissue culture activities. The laboratory skills and training include expertise in mammalian cell culture, aseptic technique, sterile media preparation, tissue culture room maintenance, routine testing for endotoxin and mycoplasma.

The successful candidate will work as part of the innovation team of NantKwest to develop next generation products for adoptive cell therapy based on the allogeneic Natural Killer (NK) platform NK-92 . Perform research and associated laboratory tasks for projects and products. Work with other scientists to design and conduct experiments on a daily basis. Design and execute experiments with minimal guidance and supervision

The Research Technician performs routine laboratory research and development services. Works with a multidisciplinary team. Under nominal direction, performs a variety of basic and general laboratory research and sample management tasks determined by the field and scope of the research project. 

Analyzes specimens and maintains equipment in good operating condition. Verify the proper specimen being analyzed and perform tests that need to be completed. Analyze clinical laboratory specimens following the standard methods and procedures in an efficient manner with little to no errors. Responsible for maintaining updated understanding and knowledge of methods performed in the lab. Follows GLP (good laboratory practice): maintain clean and organized work space. etc.

Production Engineer - Statistics performs basic data analysis to manage daily operations for the product and its algorithms. Manage daily operations for the product algorithms. Track issues, coordinate new feature releases, and provide data analysis support to laboratory operations. Interface effectively with cross-functional teams within the company, including lab operations and software engineering. Be the "go to" person for data and algorithms issues. Track ongoing product performance metrics and investigate any variations, in cooperation with lab operations.

Perform transactions on corporate computer inventory control system and customer relations database based on requirements of the position. Provide important data to management for regular reports. Prepare tested assemblies for customer. Develop and/or design test processes/procedures based on product specifications. Proactively problem solves departmental related issues independently and mentors other technicians in this process

Responsiblities include: Test and calibrate assemblies to meet quality standards as well as perform electronic calibration and verify fixtures. Trouble shoot assemblies independently with exceptional computer skills. Maintain a strong commitment to high quality work with less than 2% failure rate on repairs. Maintain a 10 business day repair turnaround time on customer owned properties. Maintain minimum stock with refurbished parts to assure same day order fulfillment to assure best in class customer satisfaction

The Laboratory Analyst conducts testing in accordance with established procedures using Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), and under the supervision of the Study Director. Additionally, Laboratory Analysts record data concurrently, maintain traceability of samples throughout testing and notify the Study Director of any unforeseen circumstances that occur during testing.

Responsible for preparing, executing and finalizing test method validations, equipment, system and utility IQ, OQ and PQs as well as maintain control charts.  Also, required to maintain the re-qualification schedule per the current validation master plan schedule.

The ideal candidate will have a B.S. in a science discipline, good communication skills including customer interaction, strong work ethic and laboratory experience is a plus. The selected candidate will manage the on-line sample analysis request program and log in samples received, analyze samples with Neogen’s test kits, according to kit instructions, generates and analyzes data from a variety of laboratory techniques and analytical instrumentation, calibrate analytical instrumentation and ensure all lab equipment is up to date per ISO requirements, perform tasks essential to maintaining ISO Certification, participate in sample proficiency programs, tabulates and graphs data, and prepares technical reports for senior personnel.

Establish and maintain customer portals for PO entry and invoicing. Direct contact with customers and work closely with company Data Administrator, IT, Accounting, Customer System Information Manager, and CS Manager to provide requested services from customer. Oversee customer complaint database (CMS) – from entry to resolution.

Assembles and packages diagnostic test kits used in the food safety industry according to Standard Operating Procedures ensuring accuracy and quality throughout the assembly process. Dispense bulk solutions and blended powders into final product packaging. Complete production paperwork, including quantities produced, scrapped and in-process.

Work with Engineering, R&D, and external subcontractors to develop test methods and execute testing used in the verification and validation of designs. This includes the design and fabrication of test jigs and equipment suitable for the characteristics being tested. This also includes the drafting of protocols and reports that adequately summarize the testing performed and are suitable for review by the appropriate regulatory authorities. Participateas part of a team undertaking all phases of the development process –from planning and proof-of-concept activities through to product launch

Manufacturing Associate, Labeling and Packaging are required to have a strong knowledge of process development experience, work flow understanding, Labeling Reconciliation, Reading and Understanding Labeling and Packaging Specifications. Carry out work in accordance with defined Quality Management System procedures and be fully supportive of Quality initiatives. Prepare room for staging, packaging, and reconciliation. Assist in maintaining fixtures, packaging tools, packaging instrumentation, such as scanners, scales, etc. in packaging areas.

he ideal candidate must have outstanding written and verbal communication skills, a strong work ethic, and be able to multitask and prioritize responsibilities. The position requires a working knowledge of many automated components of the HTS platform utilized at Neurocrine. This candidate must be able to independently manage their workload, while simultaneously working with his/her supervisor to provide consistent support to the in vitro team on multiple new target screening and lead optimization campaigns.

The Manufacturing Engineer is responsible for supporting all aspects of Manufacturing Operations at NeuroPace. Maintain quality standards in and around manufacturing areas, ensuring a safe work environment for all personnel and helps to develop a culture of accountability, continuous improvement, and collaboration. Write, review, and improve manufacturing procedures and forms in compliance with the quality system, ensuring accuracy and consistency. Collaborate with Manufacturing and Development Engineers to create, review, and maintain manufacturing routers. Including verifying manufacturing labor times are properly calculated.

The Regulatory Operations Senior Associate will be responsible for maintaining timelines, formatting & publishing documents, assembling and building Regulatory eCTD submissions such as original INDs, IND amendments and/or CTAs and overseeing & archiving submissions. All will be done in accordance with and requires knowledge in applicable Regulatory Agency regulations, guidelines, and/or specifications (FDA, EMA, ICH, etc). Responsible for formatting, editing, proofing, bookmarking and internal document hyperlinks according to guidance and internal processes. Troubleshoot and resolve complex document issues.

We are currently offering a unique opportunity for a highly motivated development associate to join our team with development experience in cell therapy. Responsibilities include: Support process development of phase appropriate cell therapy production processes. Evaluate raw materials and culture systems for use in cell therapy manufacturing processes. Support process optimization efforts to increase process robustness, reduce costs and improve yield. Design and execute experiments independently; accurately record, analyze and communicate data to senior staff and team members

The Operator is responsible for operating medical balloon machines and for 100% inspection of each medical balloon produced. Understand the need to deliver quality product and demonstrate a commitment to quality. Contribute to continuous improvement and Lean initiatives. Follow controlled environment protocols for hygiene and gowning. Maintain regular attendance. Operate medical balloon machines with simple process / materials such as PET, Nylon, and Urethane

Position consists of manufacturing of medical components in a clean room environment while under general supervision in accordance with specifications and written procedures. This position may include machine operation, manual production using hand tools, visual inspection, physical measurements, and packaging of finished product. This position requires the ability to work with small and delicate components using a high degree of dexterity and accuracy.

Electrical and mechanical aptitude with the ability to design, fabricate and wire electrical control panels and test fixtures. Troubleshoot and repair circuit boards and electronic assemblies to the component level. Write comprehensive documentation on tester hardware and software designs. Develop work instructions for system users. Provide troubleshooting support to engineering and assembly teams on products and processes

coordinates the development and implementation of the quality system, researching, developing and implementing process improvements necessary to eliminate waste and reduce inventory. Responsible for development of the performance metric system used to report on continous process improvements.

The Method Development and Analytical Services (MDAS) Research Associate is an experienced resource in performing sample testing and validating the methods necessary to support development and commercialization of pharmaceutical products. The MDAS Research Associate is responsible for performing the bench chemistry testing of pharmaceutical products supporting development of new products, incoming transfer of existing products, and analytical support of product life cycle management. The MDAS Research Associate will assist in performing method development, transfer, validation, and/or verification for methods related to analyzing raw materials, semi-finished/finished products, and stability. Customer communication and active participation as the analytical chemistry expert on work teams may be required.

The Chemical Filling Operator ( Second Shift) is responsible for the proper filling, sealing and labeling of various reagents. Responsibilities: Monitoring and maintenance of the filling equipment during operation, recording necessary data into procedures, inspection of product, loading/unloading product from equipment and movement of materials.

We are seeking to hire an entry-level microbiologist. The positionwill involveworking with a team of scientists to discover new antibiotics from newly cultured species from soil and marine environments. The work will include special projects as well as daily lab tasks such as reagent prep,record keeping, and equipment maintenance.

Filling of insulin and media preparations under aseptic conditions and operation of inspection equipment to achieve production goals. Operating, monitoring and controlling equipment, systems and processes associated with the Vial/Cartridge filling and inspection lines. Maintaining aseptic areas and performing sanitizations and environmental monitoring. Assist during equipment maintenance including restoration of lost function, predictive and preventative maintenance

The Pharmacy Technician will be responsible for assisting the Pharmacy Manager with all aspects of drug handling and storage to assure drug availability and correct dosing according to the protocol.  Responsible for handling the receipt, storage, and return to sponsor along with test articles used in clinical studies.  Responsible for maintaining daily records of storage conditions of drugs and refrigerator temperatures.  Will prepare dosage forms for clinical investigators and provide general support to the clinical operations department.

The Materials Quality Technician I is responsible for overseeing, and maintaining the laboratory equipment and area. The Materials Quality Technician I is responsible for site-wide compliance of the activities related to Materials. The Materials Quality Technician I will be interacting on a daily basis with Quality and Manufacturing Engineers and Managers. Must be able to convey laboratory practices, policies, and procedures to regulatory bodies such as FDA and notified bodies. The Materials Quality Technician I will have the training and knowledge necessary to perform the Materials laboratory functions and the administrative functions. The Materials Quality Technician I may be assigned to special projects by the Department Management that is commensurate with their level of experience. etc.

The Quality Assurance Inspector I shall be responsible for performing basic visual/dimensional/functional inspections of incoming purchased product as well as product manufactured/assembled in-house, determining whether or not product meets specifications and documenting these decisions. Essential Responsibilities: Inspect raw materials, components, assembled product, semi-finished product & finished product per inspection procedures/drawings and to print specifications. Utilize attribute and variable measuring equipment/gauges as well as mating parts to determine as found/as left conditions of product. Support the qualification/validation processes for company product. etc.

This position requires a person to perform simple set ups and operate manual/CNC equipment to manufacture medical components from raw material in a team based environment. Must be able to comply with all governing rules including S.N.E. policies and procedures and adhere to safety and cleanliness practices in the work place. This position works under close supervision. Essential Duties And Responsibilities: Machine medical components, including but not limited to: Perform simple set ups and operate manual/CNC equipment, including turning, milling, grinding, drilling, tapping, EDM and honing. etc.

Responsible for the development of manufacturing methods to produce advanced technology products. You will work under the direction of either a Sr. Engineer or Manager in the development of new processes, introduction of new products, cost reduction projects, and capital justifications. Interface with Production Supervision, Tool Design, and Tool & Die, and Maintenance with respect to manufacturing method, tooling, and equipment. Establish routings for new products and determines manufacturing cost. Contacts and reviews projects with vendors as necessary. etc.

The Financial Analyst will provide financial and commercial decision support. The individual holding this role will be required, with some guidance, to monitor the financial impact of his/her business function against plan and provide reliable and timely analysis to guide the business leaders in their decision-making process. Duties & Responsibilities: Provides financial support to the business function, under guidance of the Business Partner, or Regional Business Partner. Supports the annual budgeting and forecasting processes. Monitors key performance indicators and interprets financial and operational performance. etc.

The Group Leader is responsible for successfully leading the department’s day-to-day activities (people/equipment/processes) with regards to safety, quality, customers, and efficiencies. Duties & Responsibilities: Demonstrate leadership and accountability in providing and sustaining a positive safety culture. Provide support for safety training, meetings, and programs. Provide recognition for safe behavior through position observations. Ensure proper instruction is provided on responsibilities and safe job performance (on the job training). Provide support for safety training, meetings, and programs. etc.

Position’s primary role is that of First Impressions Coordinator: Greeting and coordinating credentials for guests and their hosts within Smiths Medical. They also play a role in meeting site security and facility needs. They act as site concierge for all guests and employees. Supports catering activities and conference room bookings. Associate will also provide back-up for the Mail Room Associate. Position reports to Facilities Manager. Duties & Responsibilities: Welcomes visitors by greeting them, in person or on the telephone; answering or referring inquiries. Directs visitors by maintaining employee and department directories; giving instructions. Maintains security by following procedures; monitoring logbook; issuing visitor badges. etc.

The Staff Accountant will support the Controller with all accounting, finance and administrative duties. Key Duties & Responsibilities: Responsible for maintaining the integrity of General Ledger accounts, structure and cost elements. Ensure monthly financial closings are in line with expectations (on time and on quality); coordinate GL resources to work according to plan (timetable, deliverables). Ensure timely and accurate financial reporting to internal/external customers (Controlling, Auditors and others). etc.

Key Job Responsibilities: Conduct routine analysis on collaborator data as it is generated by the service lab, applying standard quality assessment protocols, and providing results to collaborators. Use internally developed and off the shelf tools to process collaborator data into standard results. Apply standard quality assessment protocols to results generated and coordinate with laboratory personnel regarding assay quality and protocol deviations. Monitor and manage data flow for collaborator samples, providing regular feedback to project management. Participate in study planning calls with collaborators to discuss how their samples will be analyzed and provide recommendations based on documented best practices. etc.

WHAT WE ARE LOOKING FOR: We are looking for enthusiastic and talented individuals who thrive on challenge and change, who can roll up their sleeves, put on multiple hats and have a can-do attitude without a lot of oversight or instruction. We are currently seeking a Manufacturing Associate who will be responsible for performing Upstream manufacturing tasks. Including but not limited to: Tracking & control of raw material inventory. Maintenance and operation of equipment in cGMP facilities. Preparation of buffer and media. Assistance in operation of single use bioreactors for production of clinical and commercial products.

We are currently seeking a Manufacturing Associate responsible for performing downstream manufacturing tasks including 1) tracking and control of raw material inventory 2) maintenance and operation of equipment in cGMP facilities, 3) buffer preparation, 4) assist in setup and operation of purification equipment for production of clinical and commercial products. etc.

This individual contributes to general operations and testing for the Quality Control and Microbiology Laboratories. This position supports in-process testing and drug substance and drug product release and stability testing programs. Works independently under general supervision. ESSENTIAL DUTIES AND RESPONSIBILITIES: Routine Environmental Monitoring in aseptic manufacturing environment” active air sampling, non-variable particulate monitoring, surface and personnel sampling. Incubation and counting of plates. Bae knowledge of microbial organisms and microbiological techniques. etc.

The Scientist will: Cell banking and quality testing of prepared batches. Isolation and cryopreservation of PBMCs in the context of clinical and pre-clinical studies. Maintain cell culture facility and culture cell lines as required for experiments including but not limited to: cell expansion, cell feeding, harvesting, counting and freezing. Participate in sample management activities such as receiving, processing, storage and shipping of clinical and preclinical samples. Participate in instrument maintenance and qualification. Maintain accurate, timely and detailed records of work. With guidance and supervision from the supervisor, conduct clinical and preclinical sample analysis per SOPs and generate data with high scientific quality to meet GLP regulatory expectations. etc.

Spherotech, Inc. seeks a college graduate for a Technical Customer Support Representative opening. Duties include, but are not limited to providing customer/technical assistance and Microparticle application support. Responsibilities also include representing the company through trade shows, technical publications, and presentations. Required laboratory skills include: Analysis of Microparticles using particle sizers, flow cytometry, fluorescence spectrophotometry, and microscopy.

Spherotech, Inc. seeks a college graduate for a Quality Control Associate opening. Duties include final product inspection, documentation, Quality Control testing etc. This position requires a Bachelor's degree in Chemistry or related field and a minimum of 1 year of experience. We offer excellent benefits including paid vacation, health insurance, dental insurance, etc. Compensation commensurate with experience.

SQZ Biotechnologies is looking for a highly motivated, collaborative, and dynamic Research Associate for our Immunology team within R&D. This role is an opportunity to focus on developing novel immunotherapies for the treatment of cancer. The scope of this work will encompass the design and execution of in vitro and in vivo experiments for internally- and externally-focused research programs. This position requires effective collaboration across multiple groups and the regular presentation of scientific results to multidisciplinary teams. etc.

MAIN JOB RESPONSIBILITIES / COMPETENCIES: Thorough knowledge of all applicable SOP's: makes proper decisions in line with applicable SOPs and standards under normal conditions. Perform highly technical tasks in support of manufacturing including equipment set-up and manufacturing of product, tool changes, sterilization processes, and filtration of material and calibration activities as assigned. Troubleshoot issues on equipment and assist with preventative maintenance. Edit equipment programs (as required). Assist in revising procedures related to operation and preventative maintenance. Support qualification activities (as required). Train production operators in the processes. Other duties as assigned. etc.

The QC Data Review Specialist will be responsible for GMP review and comment on laboratory raw data, procedures and reports to ensure methods, protocols and other procedures were properly followed, results are analytically accurate and correct, and that all documentation meets GMP standards. ​Responsibilities: Review of documentation generated during method validation, method verification, stability testing, routine testing and other analyses. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness. Provide feedback from reviews to analysts and supervisor and ensure necessary action are taken to correct or prevent error. Review data using a systematic approach to ensure compliance with procedures and specifications. Review and audit projects as required. Perform other duties assigned by supervisor as needed. etc.

Manufacturing of Life Science products according to standard operating procedures and work instructions. Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting. Typically receives minimal instruction on routine work; general instructions on new assignments. Maintain a high level of productivity in the laboratory setting while following Good Laboratory Practices (GLP) Maintain a safe, pleasant and efficient work environment. Collaborate with other departments in process improvement or new product launch projects. Participate in special projects and department meetings via input, feedback and execution of assigned tasks. Manufacturing of Life Science products according to standard operating procedures and work instructions. Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting. Typically receives minimal instruction on routine work; general instructions on new assignments. Maintain a high level of productivity in the laboratory setting while following Good Laboratory Practices (GLP) Maintain a safe, pleasant and efficient work environment. Collaborate with other departments in process improvement or new product launch projects. Participate in special projects and department meetings via input, feedback and execution of assigned tasks. Manufacturing of Life Science products according to standard operating procedures and work instructions. Performs simple calculations according to procedures, and maintains accurate records of work performed according to GLP, GMP, and QSMRs. Independently prioritize work assignments and consistently demonstrate the ability to perform assigned tasks in manufacturing setting. Typically receives minimal instruction on routine work; general instructions on new assignments. Maintain a high level of productivity in the laboratory setting while following Good Laboratory Practices (GLP) Maintain a safe, pleasant and efficient work environment. Collaborate with other departments in process improvement or new product launch projects. Participate in special projects and department meetings via input, feedback and

This position supports Facilities GxP (GMP & GLP) compliance by acting as a liaison between Facilities, QC, GLP and QA. This position is responsible for supporting Facilities related incident investigations, CAPA, CAPA effectiveness, audits and other Quality System activities. This position supports the Master Equipment File (MEF) system by providing oversight of the document filing system. This position helps maintain departmental training compliance by providing administrative support. This position may help support validation by assisting with periodic reviews and other qualification activities. Drafts Facilities SOPs and work practices.

The successful candidate will be responsible for developing novel synthetic routes and chemical processes for anti-cancer drugs and proprietary drug linkers used for antibody conjugation. The ideal candidate should possess an in-depth knowledge of organic chemistry, reaction mechanisms, and familiarity with modern synthetic methods and analytical techniques. Candidates will have demonstrated creativity and independence in solving synthetic problems and ultimately developing robust chemical processes which he or she will work to transfer to CMO’s. Experience and expertise in peptide synthesis is desirable. Responsibilities: Conduct route scouting studies to establish novel synthetic routes for drug linkers and active pharmaceutical agents. Design and execute experiments which define parameters for robust and efficient chemical processes. etc.

Laboratory Bench Position that performs routine release testing for raw materials, intermediates, and final products within a cGMP environment. PRINCIPAL DUTIES AND RESPONSIBILITIES: Perform testing of raw materials and products. Perform instrument qualification and maintenance. Perform test method validation/verification. Review analytical data for completeness, accuracy, and compliance. Perform training on procedures, equipment, or quality systems. Other duties as assigned. Individual contributor, but may be assigned as a project lead or trainer commensurate with experience or expertise. etc.

The position will hold responsibility for assisting in the manufacturing of Sedia’s immunoassay product lines encompassing lateral flow and ELISA test. The holder of this position is expected to follow the guidance of their direct supervisor to assist in delivering company products in a timely and cost effective manner. The position will contribute in building product subassemblies or final assemblies. The Manufacturing Technician will adhere to all applicable regulations, policies, and procedures for health, safety, and environmental compliance.

Seer is seeking a Research Associate, Assay Development, who will implement and contribute to the design of biochemical experiments that support the development and operation of the company’s protein assays. These assays form the foundation of breakthrough products and services in proteomic data, which Seer will provide to patients and clinicians. The Research Associate, Assay Development will report to the Senior Scientist of Assay Development. The specific assays developed for Seer will leverage nanoparticles, immunoassays, as well as the use of mass spectrometry as a detection approach. The successful candidate is expected to have a background in biochemistry, biology, or pharmacology with experience in academia and/or industry, ideally within life sciences companies. Experience in industry, including the implementation of SOPs and testing in support of clinical or pre-clinical products is strongly desired. This role will be based in the South San Francisco office through late 2019. Please note, the company is moving to its permanent location in Redwood City at the end of the year.

Initiates, directs and executes pre-clinical scientific research and/or development strategies in research and/or development. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the-art principles and theories. May act as spokesperson on corporate research and development and advise top management. May participate in development of patent applications. Interfaces with various departments and serves as internal consultant. etc.

The Research Associate will be responsible for designing, executing and interpreting experiments and analytical procedures under general supervision. Opens a New Window. Initiates, directs and executes pre-clinical scientific research and/or development strategies in research and/or development. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research. Maintains broad knowledge of state-of-the-art principles and theories. May participate in development of patent applications. Interfaces with various departments. Responsibilities: In consultation with supervisor or manager, designs procedural and experimental approach to meet designated scientific objectives. Initiates and develop plans to ensure the timely completion of several sets of experiments. Performs complex analytical procedures using established techniques.

Sekisui XenoTech, LLC is currently hiring for a Research Assistant for our Enzyme Incubations Team within the Program Execution department. The Research Assistant assists with routine laboratory functions including diluting, labeling and dispensing of biological samples, reagent solution preparation, equipment repair, laboratory upkeep, maintains inventory of supplies, and various other responsibilities. Essential duties and responsibilities include, but are not limited, to the following: Design and conduct routine and atypical experiments. Maintains laboratories and equipment and performs minor repairs on equipment, with supervision. Maintains appropriate logs, records and study notebooks. Processes and reviews data. Adheres to Good Laboratory Practice regulations and Sekisui XenoTech safety policies and procedures. Sekisui XenoTech, LLC is currently hiring for a Research Assistant for our Enzyme Incubations Team within the Program Execution department. The Research Assistant assists with routine laboratory functions including diluting, labeling and dispensing of biological samples, reagent solution preparation, equipment repair, laboratory upkeep, maintains inventory of supplies, and various other responsibilities. Essential duties and responsibilities include, but are not limited, to the following: Design and conduct routine and atypical experiments. Maintains laboratories and equipment and performs minor repairs on equipment, with supervision. Maintains appropriate logs, records and study notebooks. Processes and reviews data. Adheres to Good Laboratory Practice regulations and Sekisui XenoTech safety policies and procedures.

The Research Associate's primary role is to conduct in vivo and in vitro studies to advance Selecta's drug discovery programs. Position participates in designing and executing experiments aimed at evaluating the efficacy of Selecta's nanoparticles in relevant disease models and understanding the mechanism of action of drug candidates. The position is approximately 80% lab and 20% non-lab work. Primary Duties and Responsibilities: Plan the scheduling and designing of experiments to evaluate the efficacy of nanoparticles and understanding the mechanism of action of drug candidates. Participate and sometimes take a lead role in executing animal experiments including injections and processing tissue and serum samples. etc.

Semma Therapeutics is a biotechnology company pioneering the development of a stem cell-based cure for diabetes. We are seeking an outstanding manufacturing associate for clinical materials to join our growing team. This full-time role reports to the Director of Manufacturing, and will be responsible for the technology transfer and production of cell therapy products to support Semma’s Phase I/II clinical trials. Clinical materials produced in the facility will be manufactured according to Good Manufacturing Practices (GMP) and conducted under Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). etc.

Advance SeraCare’s purpose of understanding disease by supporting the research and development of new precision diagnostic products. Support includes independently performing routine and non-routine applications of cellular/molecular genetic technology to quantitate and manipulate genetic material. RESPONSIBILITIES: Perform general molecular techniques such as nucleic acid purification, gel-electrophoresis, RNA transcription, cell culture, and bacterial culture. Perform nucleic acid analysis (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results. etc.

In this Systems Engineer role, you will support moderate to complex systems engineering projects, obtain requirements, and develop new requirements based on customer needs. You will also translate requirements into detailed systems/product specifications and participate in systems analysis as well as systems/product validation and verification. You will provide technical support to systems/product users and other partners, providing resolution to engineering problems (HW, SW, Test) and implements system improvements and reports on the effectiveness of existing and new systems/products. Responsibilities: Participate in rotational exposure to all aspects of R&D life cycle to understand products; customer requirements and interface of hardware/software and system integration. Prepares test and diagnostic programs, designs test fixtures and equipment, and completes specifications and procedures for new products under direct supervision. etc.

In this Systems Engineer role, you will provide systems engineering support on moderate to complex systems engineering projects and participate in requirements capture; develops new requirements based on customer need. You will also translate requirements into detailed systems/product specifications. In addition, you will participate in systems analysis, systems/product validation and verification and provide technical support to systems/product users and other stakeholders, providing resolution to engineering problems (HW, SW, Test). You will also implement system enhancements and report on the effectiveness of existing and new systems/products. etc.

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably. A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics. Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape. etc.

Responsibilities: Encapsulation of cells in novel biopolymer systems. Maintenance and setting up of biopolymer device encapsulation systems. Establishing protocols and SOPs for encapsulation procedure. Work in a matrixed environment to ensure biomaterials meet the needs of the in vivo and cell biology teams. With increasing independence, plan, design and execute of a series of experiments that provide the research findings necessary for the completion of an assigned project. Demonstrate understanding and application of relevant scientific literature to the design of experimental protocols. etc.

The ideal candidate will be hard-working and ready to be hands on. In this role, you will have a chance to participate daily in our research by working closely with our study directors, senior technicians, and scientists in order to conduct studies. Animal Technicians begin by learning the basics of data collection and animal husbandry and have the chance to move up into high level Technician roles. This is an entry level position and a great place to start your career in research and see where you may end up! Many of our Animal Technicians become Research Technicians, Laboratory Technicians or even Scientists as they continue to train and grow here at Sinclair.

Obtain training on different aspects of logistics and apply them consistently and efficientlyto operations hired to perform: Pulling material from warehouse using Fork truck and scissor lift when necessary. Shipping of daily client material on designated truck. Shipping of client material via FedEx, UPS, etc. Accepting client material from delivery drivers and inspecting for damage. Working to keep any client material put in appropriate bin locations when necessary to keep staging areas clear. Participate in collaborating or writing of deviations, investigations, and CAPAs to continuously improve operations. Demonstrate good documentation practices. etc.

We are currently seeking a Lab Assistant to provide assistance to our technicians and scientists. Responsibilities include: Carry out a number of procedures including preparing samples for analysis, sterilizing equipment, and general cleaning duties. Maintain working order of equipment and supplies necessary to perform analysis of food samples. Work closely with other team members and with the support of a department supervisor

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

The incumbent is responsible for performing chemical analysis on food/pharmaceutical samples. The incumbent analyzes the concentration of certain components in food samples. The incumbent must accurately prepare and process the samples to obtain the needed results. This position reports to the Supervisor of Chemistry.

Work as a member of a team to receive and log in client samples to prepare them for analysis. Review samples and documentation to assign identification numbers and enter data into our tracking system. Prepare packages for shipping and pick up by vendors. Contact clients when necessary to confirm information about test codes and sample contents. Achieve accurate, timely and consistent results to ensure samples are processed correctly

The Biomedical Engineer is responsible for facilitating the transfer, scale-up, and validation of new and improved product designs and processes into manufacturing. Also responsible for assisting and providing technical product support for other functions including regulatory, quality, manufacturing, clinical, marketing and sales.

This role is responsible for executing daily activities in the QC Laboratory including support testing for the production of Merz North America product. Oversee and/or assist with tasks related to the activities associated with operation of Merz Quality System and as directed by Quality Management. Support all activities related to analytical assessment of Merz NA products and the manufacturing environment. Advise Quality Assurance, Manufacturing and MS&T departments on matters related to analytical testing and support. Provide direct support to Quality Assurance personnel regarding operation of the department and Quality System.

The Production Control Technician I is responsible for assisting in the control of production, documentation and inventory maintenance for multiple groups within Consumable Operations.  The position will help standardize and improve documentation, manufacturing procedures and processes to increase production efficiency and ensure best practices are followed.  The position will also help implement new products, projects and processes within Manufacturing Operations.  Some degree of professional latitude, creativity and self-management is expected.

The Commissioning & Support Engineer responsibility is two-fold: it includes both on-site, hands-on installation work and remote product support. The role of commissioning engineer involves frequent travel to customer sites to configure and commission the S250-series cyclotrons under installation. During remote weeks or between installs, this role functions more like product support, responsible for providing business critical technical support to other commissioning engineers, installers, field service engineers and customers to help ensure the highest operational status possible.